A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Pfizer
Study ID
NCT07597928
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy
  • Healthy Adults

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PF-08049820 — DRUG
    Administered orally
  • Rabeprazole — DRUG
    Administered orally

Study Details

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).

Key Dates

Start date
May 12, 2026
Status verified
May 2026
Primary completion
Sep 3, 2026
Completion
Sep 25, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pfizer Clinical Research Unit - New HavenNew HavenConnecticut06511-

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