A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults
Purpose
The purpose of this study is to learn how different forms of the study medicine called PF-08049820 are absorbed and eliminated in healthy adults. The study will assess whether the study medicine is absorbed differently when taken with or without food. It will also assess absorption when the study medicine is taken with another medicine called rabeprazole. Rabeprazole is an FDA approved medicine that reduces stomach acid. The study has two parts. In Part A, participants will take three forms of study medicine, one after the other. They will take each form either with or without food for a total of five doses. Each dose will be separated by a few days. Participants will stay in the clinic for about two weeks. They will receive a telephone follow-up call about a month after the last dose. In Part B, participants will take three forms of study medicine. They will take each one with or without food, and with or without another medicine called rabeprazole. This means they will take a total of six doses of study medicine. Each dose will be separated by a few days. Participants will stay at the clinic for about three weeks, and about a month after their last dose. They will get a follow-up phone call. Part B may or may not be conducted depending on the results from Part A. The study is seeking participants who: 1. Are males or females, 2. Are at least 18 years of age, 3. Have a body mass index (BMI) 16 to 32 kilograms per meter squared (kg/m2). Have a total body weight of more than 50 kilograms (kg) (110 pounds).
Conditions
- Healthy Adults
- Healthy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Healthy males and females. 2. At least 18 years of age 3. Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.).
Exclusion Criteria
- Evidence or history of clinically significant medical conditions. 2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B or hepatitis C. 3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. 4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Sequence 1 (Part A) |
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
|
|
Experimental Sequence 2 (Part A) |
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
|
|
Experimental Sequence 3 (Part A) |
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
|
|
Experimental Sequence 4 (Part A) |
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
|
|
Experimental Sequence 5 (Part A) |
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
|
|
Experimental Sequence 6 (Part A) |
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
|
|
Experimental Sequence 7 (Optional Part B) |
3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions. |
|
Recruiting Locations
New Haven, Connecticut 06511
More Details
- Status
- Recruiting
- Sponsor
- Pfizer