Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 days plus 5 half-lives before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 of the study. o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 days starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 2 contracts
Sources: Informed Consent Document, Informed Consent Document
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You may be eligible to participate must weigh more than 110 lb (99 lb if you have well controlled hypertension or hyperlipidemia (high cholesterola Japanese participant) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 between: o Part A, B, and C – 40 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 7 days plus 5 half-lives before the first dose or at any time during the study o The You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study investigator or study staff will review a list of these medications and substances with you ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, Pinhibitors or inducers of certain enzymes or proteins within 14 days or 5 half-gp/MDRI, OATP1B, lives (which is drug dependent); before the first dose or UGT1A1 and UGT1A4 substrates after Day -1 of at any time during the study. study o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely while o You can drink water freely if you are in the CRU Part B or C • You If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed during • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 2 contracts
Sources: Informed Consent Document, Informed Consent Agreement
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which that may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to abstain from strenuous or endurance exercise through visit 4 of the approved label study • You must not have a history of phototoxicity or photosensitivity severe adverse reaction associated with any vaccine and/or severe allergic reaction (for example, anaphylaxis) to any component of the study vaccine • You must not have a current compromised immune system with known or past diagnosis suspected deficiency of type 1 or type 2 diabetes mellitus your immune system • You must not have a personal or family history of medullary thyroid cancer autoimmune disease (MTCyour immune system attacks your body) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder an active autoimmune disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 days plus 5 half-lives before the first dose or at any time during the study requiring treatment o The study investigator or study staff will review a list of these medications and substances diseases with you o Before taking • You must not have any drugs condition associated with prolonged bleeding that might affect your ability to receive an IM injection • You must not have a prior history of heart disease, including prior diagnosis of coronary artery disease, myocarditis, pericarditis, uncontrolled high blood pressure, or heart failure • Hormonal birth control (detailed earlier in this document) is allowed • Unless considered medically necessary, no vaccines other than the study drugsvaccines should be given within 14 days before the first study vaccine and 14 days after the second study vaccine • If enrolled in dosing groups 1 and 2, you must call not have had any modRNA vaccines within 28 days before the CRU for approvalfirst study vaccine and 28 days after the second study vaccine. It If enrolled in dosing group 3, you must not have had any modRNA vaccines within 60 days before the first be approved by study vaccine and 60 days after the second study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the studyvaccine. • You must not have taken had any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, Pother (non-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 of the study. o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist ) flu vaccine within 90 days 6 months (175 days) before the first dose study vaccine through completion of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You may only participate in one part of this study • You must not have donated blood for at least received any chronic medications with known systemic immunosuppressant effects, radiotherapy, or cytotoxic agents (cancer treatments) within 60 days before dosing. Plasma study enrollment through the end of the study • You must not have received systemic corticosteroids (greater than 20 mg/day of prednisone or equivalent) for greater than or equal to 14 days from 28 days before enrollment in the study through 28 days after the last study vaccine • You must not have received a blood or plasma (a component of blood) donation products or immunoglobulins (proteins) within 60 days before study enrollment through the end of the study • You must not take medications that prevent fever, or other pain medication to prevent symptoms associated with the study vaccines o You may be allowed o to take such medications if you are taking them for a medical condition • You canmust not donate any blood or blood products at any time be participating in other studies involving receipt of an investigational product within 28 days prior to study entry and/or during this study. Donation is not allowed for at least 4 weeks after your last blood draw study participation • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positivepositive for anything other than cannabinoids, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU should avoid strenuous or endurance exercise through Study Visit 4, for 24 days starting example hiking uphill or with checka heavy backpack, high-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator intensity muscle-strengthening activity (like resistance or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include weights), running, swimming laps, aerobic dancing, heavy liftingyardwork such as continuous digging or hoeing, weight trainingtennis (singles), cycling 10 miles per hour or faster, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days jumping rope This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Document
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 7 days plus 5 half-lives before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o • You must tell the study staff about any drugs taken during the study o Use • You must not take hormone replacement therapy (HRT), hormonal methods of certain medications that are unlikely to interfere with birth control within 28 days before the study results first dose. These may not be allowed but the dose of these background medications should stay the same taken at any time during the study. Depo-Provera® must be discontinued at least 6 months before the first dose • You must not have taken any medicationstake MAO inhibitors (used to treat depression, dietary or herbal supplements that are sensitive CYP3Aanxiety, BCRP, P-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 of headache) within 14 days before the study. first dose o The study investigator or study staff will review a list these types of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before during the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists screening process • You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study • You must not have received the COVID-19 vaccine within 7 days before dosing or be scheduled to be vaccinated at any time while confined to the CRU for the study • You may only participate in one part be asked to provide documentation of this study your childbearing status • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco have any significant medical or nicotine-containing products in excess psychiatric condition, including recent (within the past year) or active thoughts of suicide or suicidal behaviors, as determined by the equivalent of 5 cigarettes study investigator that may put your safety at risk or 2 chews of tobacco per day could have an effect on the study results • You must not use tobacco- have a history of bone marrow suppression • You must not have a history of aplastic anemia or nicotineagranulocytosis • You must not have a history of a seizure disorder • You must not be shown to carry or be positive for ▇▇-containing products ▇-▇*1502 and HLA-A-1302 o These are markers for 24 hours before the first dose and while confined to the CRU carbamazepine-induced SJS • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 18 days in a row starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You canmust not lie down use tobacco- or nicotine-containing products for 4 24 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your before the first admission dose and while confined to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything (except water water) for at least 10 hours before each safety laboratory test and 4 hours after dosing with study drug and ritonavir in both study periods. You may drink water freely, except for 1 hour before and 1 hour after these doses. • There are no food or water restrictions around carbamazepine dosing. • You must not eat or drink anything (except water water) for at least 10 4 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT each safety laboratory tests • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will You must be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary willing to split doses and dose twice a day, eat the timing of meals or snacks may be changed food offered during the study • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Agreement
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, , minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 7 days plus 5 half-lives before the first dose or at any time during the study o The study investigator or study staff will review a list Hormonal methods of these medications and substances with you birth control are allowed o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary medications or herbal supplements substances that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1Bstrong inducers of CYP3A4 (a gene that alters enzyme activity in the body) within 28 days of the first dose, or UGT1A1 take any strong inhibitors of CYP3A4 during the study and UGT1A4 substrates for at least 4 days after Day -1 of the study. last dose o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study • You must not have a history of sensitivity to ritonavir, or any of the components of the study drug or ritonavir • You must not have received the COVID-19 vaccine within 7 days before screening or admission to the CRU or be scheduled to be vaccinated at any time while confined to the CRU for the study • You may only participate in one part be asked to provide documentation of this study your childbearing status • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not use tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day o You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco have any significant medical or nicotine-containing products in excess of psychiatric condition, as determined by the equivalent of 5 cigarettes study investigator that may put your safety at risk or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before could have an effect on the first dose and while confined to the CRU study results • Please let us know if you or a relative are a study staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 16 days in a row starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after each morning dosing on days when blood samples for with study drug levels are collectedand ritonavir, unless needed for any study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission will be confined to the CRU through your last follow-up contact with procedure room for the CRU o You should apply sunscreen with a sun protection factor (SPF) first 4 hours after dosing on Day 1 of greater than or equal each period, except to 50 and wear eye-protective sunglasses use the bathroom • You must not eat or drink anything (except water water) for at least 10 4 hours before each safety laboratory lab test • You must not eat or drink anything except water for at least and 10 hours before the collection of the pre- pre-dose blood sample for study drug and other pre-dose blood samples ritonavir on Day 1 of each period • You Except for one hour before and one hour after dosing on Day 1 of each period, you may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug and ritonavir • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period and ritonavir o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period and ritonavir o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug and ritonavir o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 4 hours after dosing in each period • Dinner will be provided about 9-9 – 10 hours after dosing in each period • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing permitted on Day 1 of meals or snacks may be changed each study period • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Document
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which that may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 28 days plus 5 half-lives before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken been vaccinated with a COVID-19/flu vaccine within 7 days before screening or admission or are scheduled for a COVID-19/flu vaccine at any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 of time during your confinement at the study. o The study investigator or study staff will review a list of these medications and substances with you CRU • You must have taken a GLP-1R agonist within 90 days before test negative for COVID-19 at the first dose time of Saxenda • You must not have a known intolerance or hypersensitivity admission to Saxenda or other GLP-1R agonists the CRU • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons1/3 of a cup) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). ) o Urine tests will be done to check for such drugs. drugs o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a A study staff member of the same sex may monitor urine collection o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not have hypersensitivity or previous serious/significant adverse events due to antifungal medications in the same family as itraconazole • You must not have any medical conditions, medical history, or are taking any medications that are contraindicated in the itraconazole prescribing information • You must not use tobacco or nicotine-containing products in excess of more than the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- tobacco or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 days 12 overnights, starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You cannot lie down for 4 hours after each dose of study drug (Period 1, Day 1 and Period 2, Day 4), unless needed for any study procedures • You may be asked to wear a device (similar to like a wristwatch) that can be used to alert study staff in case of an emergency • You canmust not lie down eat or drink anything (except water) for at least 10 hours before the dose of study drug on Day 1, Period 1, and the dose of itraconazole on Day 4, Period 2 o Except for 1 hour before and 1 hour after dosing with the study drug, you may drink water freely • You must not eat anything for at least 4 hours after before each dose of itraconazole when given alone o There are no water restrictions when dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses itraconazole alone • You must not eat or drink anything (except water water) for at least 10 4 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT • You must not drink that has red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Breakfast will be provided about 1 hour after dosing with itraconazole alone, it will not be provided on study drug dosing days (Period 1, Day 1 and Period 2, Day 4) • Lunch will be provided about 4–5 4 hours after dosing the last dose of the morning of either itraconazole or study drug • Dinner will be provided about 9-10 hours after dosing the last dose of the morning of either itraconazole or study drug • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary You must be willing to split doses and dose twice a day, eat the timing of meals or snacks may be changed • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other food offered during the study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Document
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 7 days plus 5 half-lives before the first dose or at any time during the study o The study investigator or study staff will review a list Hormonal methods of these medications and substances with you birth control are allowed o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary medications or herbal supplements substances that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1Bstrong inducers of CYP3A4 (a gene that alters enzyme activity in the body) within 28 days of the first dose or during the study, or UGT1A1 take any strong inhibitors of CYP3A4 during the study and UGT1A4 substrates for at least 4 days after Day -1 of the study. last dose o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity to ritonavir, or any of the components of the study drug or ritonavir • You must not have received the COVID-19 vaccine within 7 days before screening or admission to the CRU or be scheduled to be vaccinated at any time while confined to the CRU for the study • You may only participate in one part be asked to provide documentation of this study your childbearing status • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not use tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day o You must not use tobacco- or nicotine-containing products for 24 hours before dosing. You cannot use these products, including vaping, while in the CRU • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco have any significant medical or nicotine-containing products in excess of psychiatric condition, as determined by the equivalent of 5 cigarettes study investigator that may put your safety at risk or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before could have an effect on the first dose and while confined to the CRU study results • Please let us know if you or a relative are a study staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 16 days in a row starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after each morning dosing on days when blood samples for with study drug levels are collectedand ritonavir, unless needed for any study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission will be confined to the CRU through your last follow-up contact with procedure room for the CRU o You should apply sunscreen with a sun protection factor (SPF) first 4 hours after dosing on Day 1 of greater than or equal each period, except to 50 and wear eye-protective sunglasses use the bathroom • You must not eat or drink anything (except water water) for at least 10 4 hours before each safety laboratory lab test • You must not eat or drink anything except water for at least and 10 hours before the collection of the pre- pre-dose blood sample for study drug and other pre-dose blood samples ritonavir on Day 1 of each period • You Except for one hour before and one hour after dosing on Day 1 of each period, you may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug and ritonavir • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period and ritonavir o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period and ritonavir o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug and ritonavir o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 4 hours after dosing in each period • Dinner will be provided about 9-9 – 10 hours after dosing in each period • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing permitted on Day 1 of meals or snacks may be changed each study period • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Document
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which that may put your safety at risk or could have an effect on the study results • You may be eligible must not have evidence of a prothrombic state (condition associated with blood clots) as demonstrated by any of the following (Part A only): o History of DVT, pulmonary embolism (blood clot in the lungs), arterial thrombosis (blood clot in an artery) o Known genetic (inherited from a parent) predisposition based on medical history ▪ The Study Investigator will review these conditions with you o Any abnormalities in clinical lab tests at screening associated with coagulation system abnormalities • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must not have a history of photosensitivity or phototoxicity (skin reactions in response to participate if you have well controlled hypertension or hyperlipidemia (high cholesterollight) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 7 days plus 5 half-lives before the first dose or at any time during the study o The You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study investigator or study staff will review a list of these medications and substances with you o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary medications or herbal supplements substances that are sensitive CYP3A, BCRP, Pmoderate or strong CYP3A4 (a gene that alters enzyme activity in the body) inducers or time-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 dependent inhibitors within 14 days plus 5 half-lives (which is drug dependent) of the study. first dose or during the study o The study investigator or study staff will review a list of these medications and substances with you • You must not have taken been vaccinated with a GLP-1R agonist COVID-19 vaccine within 90 7 days before the first dose of Saxenda • You must not have screening or within 7 days before any study visit in which a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists safety lab is scheduled • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You may only participate in one part of this must not have had previous exposure to the study drug • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 18 days (Part A) starting with check-in • You will need to stay in the CRU for 23 (Dosing Sequence 1) or 18 (Dosing Sequence 2) days (Part B) starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours after morning dosing on Day 7, 10 and 14 (Part A only) during continuous cardiac monitoring, except to use the bathroom • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collectedDays 1, 7 and 14 (Part A) or Day 1 of each period (Part B), unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything except water for at least 10 4 hours before each safety laboratory test and 8 hours before the collection of pre-dose study drug levels and PD biomarker samples (Part A) • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other predosing or eating a high-dose blood samples • You may drink water freely while in the CRU fat breakfast (Part B) • You must not eat or drink anything except water for at least 10 hours before eating breakfast • If morning dosing when an OGTT will be done on Day 1, 7, and 14 if dosing under fasting conditions (Part A) o Except for 1 hour before and 1 hour after morning dosing you must not eat anything for at least 10 hours before dosing and/or OGTT may drink water freely • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Breakfast or Ensure Plus® (or similar protein rich meal) will be provided about 30 or 20 minutes, respectively, before morning dosing o No food or drink, except water, will be allowed for at least 4 hours after dosing • Lunch will be provided about 4–5 4 hours after dosing and at the same time on Day-1, if applicable • Dinner will be provided about 9-10 hours after dosing and at the same time on Day-1, if applicable • An evening snack may be is allowed about 12-13 hours after o When dosing • If it is necessary to split doses and dose twice a dayday (Part A only), the timing of snack will be given about 20 minutes before dosing and should be completely eaten within 10 minutes • You will be given the same meals or snacks may be changed on Day 1, 7 (same breakfast only), 14, and -1, if applicable (Part A) • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU• You are encouraged to eat your entire meals on Day -1, meals 1, 7, and 14, and evening snacks will be provided at about the same time as when given on dosing days Day - 2, -1 and 13 (Part A) This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Agreement
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which may put your safety at risk or could have an effect on the study results • o You may be eligible to participate if you must not have well controlled hypertension suicidal thoughts associated with actual intent and method or hyperlipidemia (high cholesterol) by either diet plan in the past year o You must have a previous history of suicidal behaviors in the past 5 years o You must have any lifetime history of serious suicidal thoughts or stable doses of 2 behavior or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 recurrent suicidal behavior • You may be asked to provide documentation of your childbearing status • You must not be eligible shown to carry or be prescribed Saxenda, and willing to selfpositive for HLA-administer according to the approved label B*1502 or HLA-A*3101 alleles • You must not have a history of phototoxicity aplastic anemia or photosensitivity agranulocytosis • You must not have a current or past diagnosis history of type 1 or type 2 diabetes mellitus bone marrow suppression • You must not have a personal or family history of medullary thyroid cancer mixed seizure disorder that includes atypical absence seizures (MTCpetit mal seizures involving brief and sudden lapses of consciousness) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime liver porphyria • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins), hormonal methods of birth control, or hormone replacement therapy within 28 days or 5 half-lives (whichever is longer) that are inhibitors or inducers of certain enzymes or proteins within 14 days plus 5 half-lives before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you o Before taking any drugs other than the study drugsdrug, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 take MAO inhibitors within 14 days of the study. first dose o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist not take any investigational product (drug or vaccine) within 90 30 days or 5 half-lives (whichever is longer) before the first dose of Saxenda • You must not have a known intolerance this study or hypersensitivity to Saxenda or other GLP-1R agonists at any time during this study • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component history of blood) donation may be allowed o You cannot donate sensitivity reactions to carbamazepine or any blood of the components of the study drug or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw carbamazepine • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 18 days starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after dosing on the days when blood samples for you are dosed with the study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything except water for at least 10 4 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of dosing with the pre- dose blood sample for study drug in Periods 1 and other pre-2 • Except for 1 hour before and 1 hour after each dose blood samples • You of study drug, you may drink water freely while in • Carbamazepine can be given with or without food, except for the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing day when an OGTT it is given with the study drug, when you will be done you must not eat anything fast for at least 10 hours before dosing and/or OGTT o There are no water restrictions for carbamazepine dosing, except when given with the study drug • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through while confined to the collection of the last blood sample for study drug in each period CRU o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through while confined to the collection of the last blood sample for study drug in each period CRU o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 4 hours after dosing the last dose of the morning for either study drug or carbamazepine • Dinner will be provided about 9-10 hours after dosing the last dose of the morning for either the study drug or carbamazepine • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days, including the days o On non-when dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days only with carbamazepine This study is for research purposes only. There may will be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Document
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • For the optional Japanese cohort, you must have 4 Japanese grandparents who were born in Japan and • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, neoplasia type 2 (MEN2MEN2 – an inherited condition associated with 3 main types of tumors, including MTC), or be suspected of having MTC as determined by in the judgement of the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history may be asked to provide documentation of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime childbearing status • You must not take any prescription or nonprescription medications (including over-the-counter medications, medications such as medications for cold colds or allergies, antacids, dietary and herbal supplements, minerals, or vitamins) within 7 days or 5 half-lives (drug dependent), whichever is longer, before the first dose o You must not take any medications or substances that are strong inducers or inhibitors or inducers of certain enzymes or proteins CYP3A4 within 14 days plus 5 half-lives before the first dose or at any time during o A member of the study o The study investigator or study staff will review a list of these types of medications and substances with you o • You must not take hormone replacement therapy within 28 days before the first dose and remain off hormone therapy for the duration of the study • Before taking any drugs other than the study drugsdrug, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 of the study. o The study investigator or study staff will review been in a list of these medications and substances clinical trial with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any an investigational product (drug or vaccine) within 30 days or 5 half-lives, whichever is longer, before the first dose of this study • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. drugs o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose dosing and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 4 days starting with each check-in (Cohorts 1 and 2), or 18 days starting with check-in (Cohort 3) o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You cannot lie down for 4 hours after each dose unless needed for study procedures • You will be confined to the procedure room for the first 4 hours after each dose during continuous heart monitoring, except to use the bathroom • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything (except water water) for at least 10 8 hours before each safety laboratory lab test • You must not eat or drink anything (except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything water) for at least 10 hours before dosing and/or OGTT or eating breakfast o Except for 1 hour before and 1 hour after dosing, you may drink water freely • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dosedosing. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Breakfast will be provided if dosing in a fed state • Lunch will be provided about 4–5 4 hours after dosing • Dinner will be provided about 9-9 to 10 hours after dosing • An evening snack may be allowed about 12-13 hours • You may delay or skip meals after dosing • If it is necessary to split doses and dose twice a day, the timing or be offered alternative meals in case of meals nausea or snacks may be changed vomiting • Meals (breakfast, lunch, dinner, and evening snacks) on all other days will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Agreement
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 7 days plus 5 half-lives before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use You must not have been vaccinated with a live or attenuated (weakened) vaccine or any live viral components within 6 weeks before the first dose or expect to be vaccinated during treatment or during the follow-up period of certain medications that are unlikely to interfere with the study results may be allowed but There is no restriction on vaccination for COVID-19 if the dose of these background medications should stay the same during the study. vaccine is not live attenuated • You must not have taken any medicationsvisible skin damage or skin condition (such as sunburn, dietary or herbal supplements that are sensitive CYP3Aexcessively deep tan, BCRPuneven skin tones, P-gp/MDRItattoos, OATP1Bscars, excessive hair, numerous freckles, or UGT1A1 and UGT1A4 substrates after Day -1 other disfigurations) in or around the application site(s) which, in the opinion of the study. o The study investigator or study staff investigator, will review a list interfere with the evaluation of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda test site(s) reaction • You must not have a known intolerance history of or hypersensitivity to Saxenda have active AD, eczema or other GLP-1R agonists urticaria (hives/rash) • You must not have a history of systemic (affecting the entire body) infection requiring hospitalization, injection or intravenous (IV) therapy, or otherwise judged clinically significant by the study investigator within 6 months before Day 1 of the study • You must not have a history (single episode) of disseminated (widespread) herpes zoster (shingles) or disseminated herpes simplex (includes oral and genital), or recurrent (more than 1 episode of) localized dermatomal herpes zoster (shingles in a single location) • You must not have had an acute (comes on quickly and lasts a short time) disease state (for example, nausea, vomiting, fever, or diarrhea) within 7 days of Day 1 of the study • You must not have any cancers or a history of cancer with the exception of adequately treated or excised (removed) non-cancerous basal or squamous cell skin cancer • You must not have an immediate family member with hereditary (inherited from parents) immunodeficiency (compromised immune system) • You must not have a history of any lymphoproliferative disorders (diseases with uncontrolled production of lymphocytes [a type of white blood cell]) such as ▇▇▇▇▇▇▇ ▇▇▇▇ Virus (EBV – causes mononucleosis) related lymphoproliferative disorder, history of lymphoma (cancer of the lymphatic system), history of leukemia (blood cancer) or signs and symptoms suggestive of current lymphatic or lymphoid disease • You must not have undergone significant trauma or major surgery within 4 weeks of screening • You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • o You must not use tobacco- or nicotine-containing products for 24 hours before the first dose dose. You cannot use these products, including vaping, while in the CRU • You must not have a history of serious adverse reactions or hypersensitivity to any topical drug or known allergy, allergic reactions, or hypersensitivity to the study drugs or any of their components • You must be willing to refrain from shaving, the use of hair removal products or activities, antiperspirants, lotions, skin creams, fragrances or perfumes, or body oils (for example, baby or coconut oil), use of hair products, hair gels and while confined hair oils in the designated treatment areas for 48 hours before admission to the CRU and for the duration of your stay • You must not have any significant medical or psychiatric condition (including recent [within the past year] or active thoughts of suicide or suicidal behaviors), conditions or situations related to COVID-19 pandemic (for example, contact with a positive case, residence, or travel to an area with a high incidence) as determined by the study investigator that may put your safety at risk or could have an effect on the study results • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 12 days in a row starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may will not be asked allowed to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down shower within 1 hour before and for 4 hours after dosing on days when blood samples for each application of study drug levels or placebo o You are collectednot required to shower or bathe before each application • You may not use any products in the application area(s) while in the CRU • You should avoid touching the application area(s) or wiping the study drug or placebo off the application areas o You should avoid putting your hands in your mouth to avoid accidental ingestion of the study drug or placebo • You will be allowed to participate in light recreational activities during the study (for example, unless needed for study procedures watching TV or reading) • You are advised required to wear loose-fitting clothing and avoid direct sunlight activity that may cause the application to be wiped off the skin, or any high intensity UV light exposure from your first admission clothing to stick to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 application areas for at least 4 hours after morning and wear eye-protective sunglasses evening applications • You must not eat or drink anything (except water water) for at least 10 4 hours before each safety laboratory lab test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Document
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which that may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any prescription or nonprescription medications (including over-the-counter medications, medications such as medications for cold colds or allergies, antacids, dietary and herbal supplements, minerals, supplements within 7 days or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 days plus 5 half-lives (drug dependent), whichever is longer, before dosing o You must not take any medications or substances that are strong inducers or inhibitors of CYP3A4 or UGT2B7 within 5 half-lives plus 14 days (up to 28 days) before dosing o A member of the first dose or at any time during the study o The study investigator or study staff will review a list of these types of medications and substances with you o • You must not take hormone replacement therapy (HRT) or hormonal methods of birth control within at least 28 days before dosing and at any time during the study. Depo-Provera® must be discontinued at least 6 months before dosing • Before taking any drugs other than the study drugsdrug, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 of the study. o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) within 30 days or 5 half- lives before the first dose of this study • You may only participate in one part of this study dosing • You must not have donated blood for at least 60 days before dosing. Plasma (been in a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during previous study with this study. Donation is not allowed for at least 4 weeks after your last blood draw study drug • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. drugs and cotinine (a byproduct of nicotine) o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and within 3 months of screening. You cannot use these products, including vaping, while confined to in the CRU • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 5 days (Groups 1 – 5) or 10 days (Groups 6 and 7) starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You cannot lie down for 4 hours after study drug dosing unless needed for any study procedures • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything (except water water) for at least 10 4 hours before each safety laboratory lab test • You must not eat or drink anything (except water water) for at least 10 hours before the collection of the pre- pre-dose blood sample for study drug on Day 1 and other pre-dose blood samples • You for at least 4 hours after study drug dosing except for the fed treatments (Groups 5 and 7) o Except for 1 hour before and 1 hour after study drug dosing, you may drink water freely while in the CRU o There will be no water restrictions for fed dosing (Groups 5 and 7) or for rabeprazole dosing • You must not eat anything for When dosing under fed conditions (Groups 5 and 7), you will receive a high-fat, high calorie breakfast after an overnight fast of at least 10 hours before eating o Breakfast should be completely within about 20 minutes. Study drug will be given about 10 minutes after completion of breakfast • If dosing when an OGTT Rabeprazole (Groups 6 and 7) will be done you must not eat anything given about 30 minutes before a meal except for Day 1 o Rabeprazole will be given after an overnight fast of at least 10 hours on Day 1 o Study drug will be given about 4 hours after rabeprazole dosing ▪ Group 7 will receive a high-fat, high-calorie breakfast about 30 minutes before study drug dosing. Breakfast should be completely eaten within 20 minutes. Study drug will be given about 10 minutes after completion of breakfast • Lunch will be provided about 4 hours after study drug dosing and/or OGTT • Dinner will be provided about 9 to 10 hours after study drug dosing • An evening snack may be allowed • Meals (breakfast, lunch, dinner, and evening snack) will be provided at appropriate times on all other study days • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dosedosing. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be is no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Agreement
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You may be eligible to participate must weigh more than 110 lb (99 lb if you have well controlled hypertension or hyperlipidemia (high cholesterola Japanese participant) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 between: o Part A, B, and C – 40 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 7 days plus 5 half-lives before the first dose or at any time during the study o The You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study investigator or study staff will review a list of these medications and substances with you ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, Pinhibitors or inducers of certain enzymes or proteins within 14 days or 5 half-gp/MDRI, OATP1B, lives (which is drug dependent); before the first dose or UGT1A1 and UGT1A4 substrates after Day -1 of at any time during the study. study o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 14 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely while o You can drink water freely if you are in the CRU Part B or C • You If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed during • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Document
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must have 4 Japanese grandparents who were born in Japan if you are of Japanese descent • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which that may put your safety at risk or could have an effect on the study results • You must not have had any significant illness or surgery within 4 weeks before dosing o If you vomit within 24 hours of dosing, you will be carefully evaluated for any upcoming illness or disease • You must not have a clinically significant history of nasal conditions that may be eligible affect the administration or the absorption of the nasal spray • You must not have a significant history of seizure disorder other than a single childhood seizure due to participate if you a fever • You must not have well controlled hypertension a history of gallstones or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 have had your gall bladder removed • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter prescription medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitaminsincluding OATP1B3 (proteins in the liver) that are inhibitors or inducers of certain enzymes or proteins within 14 days plus or 5 half-lives (drug dependent) before dosing o A member of the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you o Hormone birth control is allowed • You must not take any over the counter medications within 7 days before dosing • You must not use nasal spray decongestants for at least 14 days before dosing through collection of the last blood sample for study drug • You must not have received a depot injection (injected medication that releases slowly over time) or an implant of any drug within 3 months before dosing • You must not take natural health products, herbal remedies, homeopathic and traditional medicines, probiotics, and food supplements such as vitamins within 7 days before dosing through collection of the last blood sample for study drug o A member of the study staff will review a list of these types of products with you • Before taking any drugs other than the study drugsdrug, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary been in a clinical trial with an investigational or herbal supplements that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1B, marketed drug product or UGT1A1 and UGT1A4 substrates after Day -1 of the study. o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist device within 90 30 days before the first dose of Saxenda dosing • You must not have been in a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists clinical trial with a biological product within 90 days of dosing • You Your nasal inspections before dosing must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You may only participate in one part of this study be normal • You must not have donated blood for at least 60 days before dosing. Plasma (a component nasal piercings or any physical findings in your nose that, in the opinion of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw the study investigator, would likely interfere with the successful completion of the dosing procedure • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. drugs o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU within 1 month of screening • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 3 days starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything (except water water) for at least 10 4 hours before each safety laboratory lab test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least about 10 hours before dosing and/or OGTT in each period • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dosedosing. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 4 hours after dosing • Dinner will be provided about 9-9 to 10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed • Meals (breakfast, lunch, dinner, and evening snacks) on all other days will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Agreement
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which that may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 7 days plus 5 half-lives before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary antibiotics or herbal supplements medications or substances that are sensitive CYP3A, BCRP, Pmoderate or strong CYP3A4 (a gene that alters enzyme activity in the body) inducers or time-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 dependent inhibitors within 14 days plus 5 half-lives (which is drug dependent) of the study. first dose or during the study o The study investigator or study staff will review a list of these medications and substances with you • You must have taken not test positive for COVID-19 at the time of admission to the CRU • You must not be at increased risk, according to the product label, if dosed with moxifloxacin (including, but not limited to participants with a GLP-1R agonist within 90 days before history of myasthenia gravis [a disease of the first dose of Saxenda immune system], tendinitis, or tendon rupture) • You must not have a known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance or hypersensitivity to Saxenda moxifloxacin or other GLP-1R agonists drugs in the same class o The study investigator or a member of the study staff will review these drugs with you • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. drugs o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • You must not have a self-reported history or risk factors for QT prolongation or torsades de pointes (for example, organic heart disease [abnormalities of the muscle tissue of the heart], congestive heart failure, hypokalemia [low blood potassium], hypomagnesia [low blood magnesium], inherited long QT syndrome, myocardial ischemia [reduced ability of the heart to pump blood], inherited deafness, family history of heart attack, sudden death, or long QT syndrome) • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 22 days starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You cannot lie down for 4 hours after morning dosing on day 3 of each period, unless needed for any study procedures • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything (except water water) for at least 10 4 hours before each safety laboratory lab test • You must not eat or drink anything for 1 hour before morning dosing on Day 1 and Day 3 of each period, except water for at least 10 hours before collection of with the pre- dose blood sample for study drug and other pre-dose blood samples • You may drink water freely while in the CRU • morning meal o You must not eat drink anything for at least 10 2 hours before eating breakfast • If after dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT on Day 3 of each period • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Breakfast will be provided about 30 minutes before morning dosing and should be entirely eaten with 20 minutes • Lunch will be provided about 4–5 4 hours after morning dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 1211-13 hours after dosing morning dosing, about 30 minutes before evening dosing, and should be entirely eaten within 20 minutes • If it is necessary to split doses and dose twice a day, the timing of meals or Evening snacks may be changed allowed • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks • You will be provided at about restricted to drinking room temperature drinks from Day 1 (before baseline ECG) until the same time as when given on dosing days final ECG measurements have been collected in each study period • You must be willing to eat the food offered during the study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Agreement
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 7 days plus 5 half-lives before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you o Before taking any drugs other than the study drugsdrug, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not take, or have taken any medicationsan anticipated need for, dietary or herbal supplements drugs that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1B, known strong inhibitors or UGT1A1 and UGT1A4 substrates after Day -1 inducers of UGT2B7 within 10 days of the study. first dose o The study investigator or a member of the CRU staff will review a list of these medications with you • You must not take certain CYP3A4 substrates (enzymes that help the body break down certain drugs in the body) o The study investigator or a member of the study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study • You must not have received the COVID-19 vaccine within 7 days before screening or admission to the CRU or be scheduled to be vaccinated at any time while confined to the CRU for the study • You may only participate in one part be asked to provide documentation of this study your childbearing status • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not currently use tobacco or nicotine containing products or have a history of use within 6 months of screening • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. drugs and cotinine o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must try to avoid direct sunlight exposure or any high intensity ultraviolet (UV) light exposure from the first day of dosing until discharge from the CRU o You must use sun cream/lotion if exposure cannot use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day be avoided. o Please also wear protective clothing and eye protection when outside • You must not use tobacco- have any significant medical or nicotine-containing products for 24 hours before psychiatric condition, as determined by the first dose and while confined to study investigator that may put your safety at risk or could have an effect on the CRU study results o You must not have a history of uveitis (swelling of the uvea [the colored portion of the eye]) • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 15 days in a row starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after each dosing on days when blood samples for study drug levels are collected, unless needed for any study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission will be confined to the CRU through your last follow-up contact with procedure room for the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal first 4 hours after each dosing, except to 50 and wear eye-protective sunglasses use the bathroom • You must not eat or drink anything (except water water) for at least 10 4 hours before each safety laboratory lab test • You must not eat or drink anything except water for at least and 10 hours before the collection of the pre- pre-dose blood sample for study drug on Day 1 of each period • Except for 1 hour before and other pre-dose blood samples • You 1 hour after dosing in the fasting period you may drink water freely; you may drink water freely while before and after dosing in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug fed periods • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed in through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the dosing until collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must Breakfast will be provided about 30 minutes before dosing when dosing in the fed state. Breakfast will not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits be given when dosing in fasting state • Lunch will be provided about 4–5 4 - 5 hours after dosing • Dinner will be provided about 9-9 – 10 hours after dosing • An evening snack may be allowed about 12-13 hours after permitted on each dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed day • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be is no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Document
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You will be asked to provide documentation of your childbearing status • You must weigh more than 110 lbs • Your body mass index (BMI) must be greater than or equal to 25.0-45.4 kg/m2 • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which that may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • o You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label not have any lifetime history of a suicide attempt • You must not have a history of phototoxicity major depressive disorder or photosensitivity history of severe psychiatric disorders (for example schizophrenia or bipolar disorder) within the last two years of screening • You must not have any condition possibly affecting study drug absorption (for example, prior bariatric surgery [such as gastric bypass], gall bladder removal, partial or complete removal of the colon, inflammatory bowel disease, or pancreatic insufficiency [pancreas does not make enough of the enzymes that the body needs to break down and absorb nutrients]) • You must not have a current history of heart attack, unstable angina (chest discomfort), arterial revascularization (for example, a stent, angioplasty, and bypass surgery), a mechanical artificial heart valve, stroke, heart failure, or past transient ischemic attack (TIA- brief stroke-like attack) • You must not have any cancer not considered cured (except basal and squamous cell skin cancer) or history of pancreatic cancer • You cannot have current, or a history of, pancreatitis, either acute (comes on quickly and lasts for a short period of time) or chronic (happens repeatedly and/or lasts a long time) • You must not have symptomatic gallbladder disease • You must not have a history or characteristics suggestive of genetic or syndromic (genetic mutation or abnormalities of the chromosomes) obesity or obesity caused by other disorders of the endocrine system (glands in the body that make and release hormones) • You must not have a known medical history of active liver disease other than fatty liver disease • You must not have a diagnosis of type 1 or type 2 T2DM or secondary form of diabetes mellitus at screening o Women with a prior diagnosis of gestational diabetes during pregnancy may be eligible to participate in this study only if they meet the other study criteria • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type neoplasia (abnormal growth of tissues) syndrome Type 2 (MEN2), ) or suspected MTC as determined by per the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime investigator’s judgement • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) that are inhibitors within 7 days or inducers of certain enzymes or proteins within 14 days plus 5 half-half- lives (drug dependent), whichever is longer, before the first dose or at any time during of study drug and throughout the study (note: some drugs may require a longer washout time than 7 days) o The Hormonal birth control that meet the study investigator or study staff will review a list of these medications and substances with you requirements are allowed o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1Bcurrently use, or UGT1A1 and UGT1A4 substrates after Day -1 have used, prohibited medications without a sufficient washout time before the first dose of the study. study drug o The study investigator or study staff will review a list of these medications and substances with you • You must have taken not take a GLP-1R agonist (a class of medications used to treat T2DM, and in some cases obesity), within 90 days before the first dose of Saxenda study drug o The study investigator or study staff will review a list of these medications with you • You must not have received a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists previous dose of the study drug • You must not take any investigational product (drug or vaccine) within 30 days or 5 half-lives, whichever is longer, before the first dose of this study • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood known intolerance or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw hypersensitivity to a GLP-1R agonist • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not use tobacco or nicotine-containing products in excess of 5 cigarette or 2 chews of tobacco per day • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. drugs and must be negative o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 days 44 overnights starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are being collected, unless needed for any study procedures • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You canmust not lie down eat or drink anything (except water) for 4 at least 10 hours after dosing on days when before collection of pre- dose blood samples for study drug levels are collecteddrug, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses eating breakfast on all dosing days • You must not eat or drink anything (except water water) for at least 10 4 hours before each safety laboratory test • You may drink water freely throughout the study You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT • You must not drink that has red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, ▇▇. ▇▇▇▇▇▇®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Breakfast will be provided at about the same time before dosing on all dosing days • Lunch will be provided about 4–5 4 to 5 hours after morning dosing • Dinner will be provided about 9-10 hours after morning dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in • You must be willing to eat the CRU, meals and evening snacks will be provided at about food offered during the same time as when given on dosing days study This study is for research purposes only. There may will be no direct benefit to you from taking part. However, but information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Appears in 1 contract
Sources: Informed Consent Agreement