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 conditions, or COVID-19 related situations (for example, contact with a positive case, residence in, 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 You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, or vitamins) within 7 days before the first dose or at any time during the study 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 You must not have taken any medications or substances that are strong inducers or inhibitors of CYP3A4 or UGT1A9 (a gene that alters enzyme activity in the body) within 28 days of the first dose through 2 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you You must not have taken any medications or substances that were highly dependent on UGT1A1 (a gene that provides the body with instructions for making enzymes) during dosing through 5 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you You must not take any investigational drugs within 30 days before the first dose 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 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. of beer, 3 oz. of wine, or 1 oz. of hard liquor You must not use tobacco or nicotine containing products within 3 months of screening or have a positive cotinine urine test 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 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 18 days in a row starting with check-in o You may need to stay in the CRU longer if you experience a longer 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 dosing with study drug, unless needed for any study procedures You should limit your exposure to sunlight/high intensity ultraviolet light and use sunscreen products with a high sun protection factor You must not eat or drink anything (except water) for at least 4 hours before each safety lab test and 10 hours before the collection of each pre-dose sample and 4 hours after each dose. Water is allowed during this time o Except for one hour before and one hour after morning dosing on Day 1 of each fasted period, you may drink water freely There are no pre-dose water restrictions for the fed 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 check-in. Alcohol is not allowed through the collection of the last blood sample for study drug 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 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 during the fed period about 30 minutes before dosing o Breakfast will not be given during the fasting periods Lunch will be provided about 4 hours after study drug dosing in each period Dinner will be provided about 9 – 10 hours after study drug dosing in each period An evening snack may be permitted on Day 1 of each study period Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study 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 conditions, or COVID-19 related situations (for example, contact with a positive case, residence in, 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 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) within 7 days before the first dose or at any time during the study 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 You must not have taken any medications take HRT or substances that are strong inducers or inhibitors some hormonal methods of CYP3A4 or UGT1A9 (a gene that alters enzyme activity in the body) birth control within 28 days of before the first dose. These may not be taken at any time during this study. Depo-Provera® must be discontinued at least 6 months before the first dose through 2 days after the last dose o The study investigator or study staff will review a list Some hormonal methods of these medications and substances with you You must not have taken any medications or substances that were highly dependent on UGT1A1 (a gene that provides the body with instructions for making enzymes) during dosing through 5 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you birth control may be allowed You must not take any investigational drugs within 30 days before the first dose of this study You must not have received a COVID-19 vaccine within 7 days before screening or admission o You must not be vaccinated with a COVID-19 vaccine at any time during the study confinement period You may be asked to provide documentation of 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. of beer, 3 oz. of wine, or 1 oz. of hard liquor You must not use tobacco or nicotine containing products within 3 months of screening or have a positive cotinine urine test 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. 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 for at least 24 hours before each dosing. o You must not smoke more than 5 cigarettes a day or consume an equivalent quantity of tobacco/nicotine containing products o You cannot use these products, including vaping, while in the CRU You must not have any significant medical or psychiatric condition, 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 18 up to 20 days in a row starting with check-in o You may need to stay in the CRU longer if you experience a longer 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 dosing with study drugmorning dosing, unless needed for any study procedures You should limit must not eat or drink anything for at least 10 hours before the Day 1 morning procedures in each period. On Day 1, you will receive breakfast approximately 2 hours before the 1st dose of study drug and ritonavir. You are encouraged to eat breakfast completely. You will receive lunch approximately 8 hours after your exposure to sunlight/high intensity ultraviolet light breakfast Except for 30 minutes before and use sunscreen products with a high sun protection factor 1 hour after each dose of study drug you may drink room temperature water freely You must not eat or drink anything (except water) for at least 4 hours before each most safety lab test and 10 hours before the collection of each pre-dose sample and 4 hours after each doselaboratory tests. Water is allowed during this time o Except for one hour before and one hour after morning dosing on You may only consume room temperature drinks from Day 1 of each fasted period, you may drink water freely There are no (prior to pre-dose water restrictions for the fed period ECG measurements) until final ECG measurements have been collected in each study period. Hot or cold drinks are not allowed during this time. 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 check-in. Alcohol is not allowed through the collection of the last blood sample for study drug 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 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 You must be provided willing to eat the food offered during the fed period about 30 minutes before dosing o Breakfast will not be given during the fasting periods Lunch will be provided about 4 hours after study drug dosing in each period Dinner will be provided about 9 – 10 hours after study drug dosing in each period An evening snack may be permitted on Day 1 of each study period study, including increased fiber content (vegetables) Meals (breakfast, lunch, dinner, and evening snackssnack) will be provided at appropriate times on all other study 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 conditions, or COVID-19 related situations (for example, contact with a positive case, residence in, or travel to, an area with a high incidence)condition, as determined by the study investigator investigator, that may put your safety at risk or could have an effect on the study results You may be asked to provide documentation of your childbearing status You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) within 7 days or 5 half- lives (whichever is longer) before the first dose or at any time during the study 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 You must not have taken take any medications or substances that are moderate or strong CYP3A/BCRP inducers or inhibitors of CYP3A4 or UGT1A9 (a gene that alters enzyme activity in the body) within 28 14 days of plus 5 half-lives before the first dose through 2 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you You must not have taken take any medications that are moderate or substances that were highly dependent on UGT1A1 strong CYP3A/BCRP inhibitors within 14 days or 5 half-lives (a gene that provides whichever is longer) before the body with instructions for making enzymes) during dosing through 5 days after the last first dose o The study investigator or study staff will review a list of these medications and substances with you You must not take hormone replacement therapy (HRT) within 28 days before the first dose. These may not be taken at any time during this study. Depo-Provera® must be discontinued at least 6 months before the first dose You must not have a known history of hypersensitivity to statin medications (rosuvastatin is a statin) You must not have a known history of sensitivity to the study drug or rosuvastatin or any of the components of the study drug or rosuvastatin You must test negative for COVID-19 at the time of admission to the CRU You must not take any investigational drugs product (drug or vaccine) within 30 days before the first dose 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. (1/3 of a cup) of wine, or 1 oz. (2 tablespoons) of hard liquor You must not use tobacco or nicotine containing products within 3 months of screening or have a positive cotinine urine test 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. You must not use these products for at least 24 hours before dosing and while in 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 18 9 days in a row starting with check-in o You may need to stay in the CRU longer if you experience a longer 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 dosing with study drugdosing, unless needed for any study procedures You should limit your exposure may be asked to sunlight/high intensity ultraviolet light wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency You must not eat or drink anything (except water) for at least 10 hours before eating breakfast on Day 1 of each period o You may drink water freely except for 1 hour before to 1 hour after rosuvastatin dosing o In study Period 2, water is not allowed after study drug dosing and use sunscreen products with a high sun protection factor before rosuvastatin dosing You must not eat or drink anything (except water) for at least 4 hours before each safety lab laboratory test and 10 hours before the collection of each pre-dose sample and 4 hours after each dose. Water is allowed during this time o Except for one hour before and one hour after morning dosing on Day 1 of each fasted period, you may drink water freely There are no pre-dose water restrictions for the fed 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 check-in. Alcohol is not allowed through the collection of the last blood sample for study drug 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 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 14 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 during the fed on Day 1 of each period about 30 minutes before dosing o Breakfast will not be given during the fasting periods Lunch will be provided about 4 hours after study drug rosuvastatin dosing in each period Dinner will be provided about 9 – 9-10 hours after study drug rosuvastatin dosing in each period An evening snack may be permitted on Day 1 of each study period allowed Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other non-dosing days You must be willing to eat the food offered during the study 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-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 conditions, or COVID-19 related situations (for example, contact with a positive case, residence in, 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 • 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) within 7 days before the first dose or at any time during the study o Before taking any drugs other than the study drugsdrug(s), 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 You must not have taken any medications or substances that are strong inducers or inhibitors of CYP3A4 or UGT1A9 (a gene that alters enzyme activity in the body) within 28 days of the first dose through 2 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you You must not have taken any medications or substances that were highly dependent on UGT1A1 (a gene that provides the body with instructions for making enzymes) during dosing through 5 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you • You must not take any investigational drugs within 30 days before the first dose of this study • You may be asked to provide documentation of 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. of beer, 3 oz. of wine, or 1 oz. of hard liquor You must not use tobacco or nicotine containing products within 3 months of screening or have a positive cotinine urine test • 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. 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 currently smoke, or use nicotine products. • You must not use tobacco- or nicotine-containing products for at least 24 hours before each dosing. You cannot use these products, including vaping, while in the CRU • You must not have any significant medical or psychiatric condition, 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 18 7 days in a row for each dosing period starting with check-in o You may need to stay in the CRU longer if you experience a longer 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 dosing with study drugdosing, unless needed for any study procedures You should limit your exposure to sunlight/high intensity ultraviolet light and use sunscreen products with a high sun protection factor • You must not eat or drink anything (except water) for at least 4 10 hours before each safety lab test and 10 hours before the collection of each the pre-dose blood sample for study drug and 4 hours after each dose. Water is allowed during this time o • You must not eat or drink anything for at least 4 hours before each safety laboratory test. Water is allowed during this time • Except for one 1 hour before and one 1 hour after morning dosing on Day 1 of each fasted perioddose, you may drink water freely There are no pre-dose water restrictions for the fed period • You must not drink red wine for 7 days before the first any dose. Red wine is not allowed through the collection of the last blood sample for study drug in each period • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before 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 • You must be provided willing to eat the food offered during the fed period about 30 minutes before dosing o Breakfast will not be given during the fasting periods Lunch will be provided about 4 hours after study drug dosing in each period Dinner will be provided about 9 – 10 hours after study drug dosing in each period An evening snack may be permitted on Day 1 of each study period • Meals (breakfast, lunch, dinner, and evening snackssnack) will be provided at appropriate times o No breakfast will be provided on all other study days the day of dosing 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-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 conditions, or COVID-19 related situations (for example, contact with a positive case, residence in, 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 • 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) within 7 days before the first dose or at any time during the study o Before taking any drugs other than the study drugsdrug(s), 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 • You must not have taken any medications take HRT or substances that are strong inducers or inhibitors some hormonal methods of CYP3A4 or UGT1A9 (a gene that alters enzyme activity in the body) birth control within 28 days of before the first dose. These may not be taken at any time during this study. Depo-Provera® must be discontinued at least 6 months before the first dose through 2 days after the last dose o The study investigator or study staff will review a list Some hormonal methods of these medications and substances with you You must not have taken any medications or substances that were highly dependent on UGT1A1 (a gene that provides the body with instructions for making enzymes) during dosing through 5 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you birth control may be allowed • You must not take any investigational drugs within 30 days before the first dose of this study • If you have received the COVID-19 vaccine, you must have completed the series (2 doses), and at least 7 days should have passed from the time of the 2nd dose to the time of screening • You may be asked to provide documentation of 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. of beer, 3 oz. of or wine, or 1 oz. of hard liquor You must not use tobacco or nicotine containing products within 3 months of screening or have a positive cotinine urine test • 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. 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 for at least 24 hours before each dosing. o You must not smoke more than 5 cigarettes a day or consume an equivalent quantity of tobacco/nicotine containing products o You cannot use these products, including vaping, while in the CRU • You must not have any significant medical or psychiatric condition, as determined by the study investigator that may put your safety at risk or could have an effect on the study results • For the (optional) Japanese group you must have 4 biological Japanese grandparents who were born in Japan • 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 18 11 to 25 days in a row (Part 1), 12 days in a row (Part 2), and 7 days in a row (Part 3) starting with check-in o You may need to stay in the CRU longer if you experience a longer 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 dosing with study drugmorning dosing, unless needed for any study procedures • You should limit your exposure will be confined to sunlight/high intensity ultraviolet light and the procedure room for about 4 hours during continuous heart monitoring, except to use sunscreen products with a high sun protection factor the bathroom (Part 1) • You must not do any strenuous activities during the period of monitoring • You must not eat or drink anything (except water) for at least 4 10 hours before each safety lab test dose/breakfast in Part 1 and 10 Part 3 and at least 7 hours before the collection of each pre-dose sample and 4 hours after each morning dose/breakfast in Part 2. Water is allowed during this time o Except If dosed under fasted conditions (Part 2) no food will be allowed 2 hours prior to and after dosing. • You must not eat or drink anything for one at least 4 hours before most safety laboratory test. Water is allowed during this time • When dosing in the fasted state except for 1 hour before and one 1 hour after morning dosing on Day 1 of each fasted perioddose, you may drink water freely There are no pre-dose water restrictions for the fed 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 check-in. Alcohol is not allowed through the collection of the last blood sample for study drug 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 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 • You must be provided willing to eat the food offered during the fed period about 30 minutes before dosing o Breakfast will not be given during the fasting periods Lunch will be provided about 4 hours after study drug dosing in each period Dinner will be provided about 9 – 10 hours after study drug dosing in each period An evening snack may be permitted on Day 1 of each study period • Meals (breakfast, lunch, dinner, and evening snackssnack) will be provided at appropriate times on all other study 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 conditions, or COVID-19 related situations (for example, contact with a positive case, residence in, 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 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) within 7 days before the first dose or at any time during the study o Hormonal methods of 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 You must not have taken any medications or substances that are strong inducers or inhibitors of CYP3A4 or UGT1A9 (a gene that alters enzyme activity in the body) within 28 days of the first dose through 2 days after dose, or take any strong inhibitors of CYP3A4 during the last dose o The study investigator or study staff will review a list of these medications and substances with you You must not have taken any medications or substances that were highly dependent on UGT1A1 (a gene that provides the body with instructions for making enzymes) during dosing through 5 at least 4 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you You must not take any investigational 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 be asked to provide documentation of 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. of beer, 3 oz. of wine, or 1 oz. of hard liquor You must not use tobacco or nicotine containing products within 3 months in excess of screening the equivalent of 5 cigarettes or have a positive cotinine urine test 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 throughout the study 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 have any significant medical or psychiatric condition, 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 18 20 days in a row starting with check-in o You may need to stay in the CRU longer if you experience a longer 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 morning dosing with study drugdrug and ritonavir, unless needed for any study procedures You should limit your exposure must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to sunlight/high intensity ultraviolet light and use sunscreen products with a high sun protection factor the CRU You must not eat or drink anything (except water) for at least 4 hours before each safety lab test and 10 hours before the collection of each the pre-dose sample and 4 hours after for study drug on Day 1 of each dose. Water is allowed during this time o period Except for one hour before and one hour after morning dosing on Day 1 of each fasted period, you may drink water freely There are no pre-dose water restrictions for the fed 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 check-in. Alcohol is not allowed through the collection of the last blood sample for study drug 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 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 during the fed period about 30 minutes before dosing o Breakfast will not be given during the fasting periods Lunch will be provided about 4 hours after study drug morning dosing in each period Dinner will be provided about 9 – 10 hours after study drug morning dosing in each period An evening snack may be permitted on Day 1 of each study period Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study 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 conditions, or COVID-19 related situations (for example, contact with a positive case, residence in, 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 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) within 7 days before the first dose or at any time during the study o Before taking any drugs other than the study drugsdrug(s), 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 You must not have taken any medications or substances that are strong inducers or inhibitors of CYP3A4 or UGT1A9 (a gene that alters enzyme activity in the body) within 28 days of the first dose through 2 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you You must not have taken any medications or substances that were highly dependent on UGT1A1 (a gene that provides the body with instructions for making enzymes) during dosing through 5 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you You must not take any investigational drugs within 30 days before the first dose of this study If you have received the COVID-19 vaccine, you must have completed the series (2 doses), and at least 7 days should have passed from the time of the 2nd dose to the time of screening 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 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. of beer, 3 oz. of wine, or 1 oz. of hard liquor You must not use tobacco or nicotine containing products within 3 months of screening or have a positive cotinine urine test 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. 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 for at least 24 hours before each dosing. o You must not smoke more than 5 cigarettes a day or consume an equivalent quantity of tobacco/nicotine containing products o You cannot use these products, including vaping, while in the CRU You must not have any significant medical or psychiatric condition, 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 18 12 days in a row starting with check-in o You may need to stay in the CRU longer if you experience a longer 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 dosing with study drugmorning dosing, unless needed for any study procedures You should limit your exposure to sunlight/high intensity ultraviolet light and use sunscreen products with a high sun protection factor must not do any strenuous activities during the period of monitoring You must not eat or drink anything (except water) for at least 4 hours before each safety lab test and 10 hours before the collection Day 1 morning dose of each pre-dose sample study drug and ritonavir and 4 hours after each dosethis dosing. Water is allowed during this time o Except for one 1 hour before and one 1 hour after morning dosing on Day 1 of each fasted period1, you may drink water freely There are no pre-dose freely, and may be encouraged to increase your water restrictions intake You must not eat or drink anything for the fed period at least 4 hours before most safety laboratory tests. Water is allowed during this time 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 check-in. Alcohol is not allowed through the collection of the last blood sample for study drug 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 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 You must be provided willing to eat the food offered during the fed period about 30 minutes before dosing o Breakfast will not be given during the fasting periods Lunch will be provided about 4 hours after study drug dosing in each period Dinner will be provided about 9 – 10 hours after study drug dosing in each period An evening snack may be permitted on Day 1 of each study period study, including increased fiber content (vegetables or prune juice) Meals (breakfast, lunch, dinner, and evening snackssnack) will be provided at appropriate times on all other study 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