A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PF-08049820, Rabeprazole.
- Who it may be relevant to
- Registry conditions: Healthy Adults, Healthy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF ONE IMMEDIATE RELEASE AND TWO MODIFIED-RELEASE FORMULATIONS OF PF-08049820 ADMINISTERED ORALLY UNDER FASTED AND FED CONDITIONS (PART A), AND A FIXED SEQUENCE STUDY TO ASSESS THE EFFECT OF RABEPRAZOLE ON THE PHARMACOKINETICS OF PF-08049820 (PART B), IN HEALTHY ADULTS
Overview
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).
Interventions
- Drug PF-08049820
Administered orally - Drug Rabeprazole
Administered orally
Primary outcome measures
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) [Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B]
- Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit [Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B]
- Maximum observed plasma concentration (Cmax) [Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B]
Secondary outcome measures (8)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B]
- Number of Participants With Serious Adverse Events (SAEs) [Time frame: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B]
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B]
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B]
- Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings [Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B]
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) [Time frame: Baseline up to Day 16 for Part A]
- Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit [Time frame: Baseline up to Day 16 for Part A]
- Maximum observed plasma concentration (Cmax) [Time frame: Baseline up to Day 16 for Part A]
Eligibility criteria
Inclusion criteria
- Healthy males and females.
- At least 18 years of age
- 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.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B or hepatitis C.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Pfizer Clinical Research Unit - New Haven — New Haven
Identifiers
NCT: NCT07597928 · C6231008