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Relative Bioavailability and Impact of Rabeprazole for PF-07799933, Food-Effect for PF-07799933 and PF-07799544
Sponsor: Pfizer
Summary
The purpose of this study is to evaluate the relative bioavailability (rBA) of the Form 2 film-coated tablet of PF-07799933 intended for use in future studies compared to the current Form 1 tablet of PF-07799933 used in Phase 1 studies. Additionally this study will also evaluate the effect of a high-fat meal on the plasma pharmacokinetics (PK), i.e, the rBA compared to overnight fasting, of PF-07799933 and PF-07799544 following concurrent single-dose oral administration of Form 2 film-coated tablet formulation of PF-07799933 with PF-07799544. Finally, this study will also assess the impact of a proton pump inhibitor (a type of acid reducing agent) on PF-07799933 PK of the Form 2 film-coated tablet formulation. These data will be used to inform administration of PF-07799933 and PF-07799544 with food and acid reducing agents in future clinical trials.
Official title: A Phase 1 Open-Label, Single-Dose, Two Cohort Crossover Study to Evaluate the Relative Bioavailability of a Test Formulation of PF-07799933 and the Effect of a High-Fat Meal on Plasma Pharmacokinetics of PF-07799933 and PF 07799544 Administered in Combination, and the Impact of a Proton Pump Inhibitor on the Plasma Pharmacokinetics of PF-07799933, in Healthy Participants.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2026-04-10
Completion Date
2026-06-24
Last Updated
2026-05-22
Healthy Volunteers
Yes
Conditions
Interventions
PF-07799933 tablets with PF-07799544 fasted
Participants receive Form 1 in a single dose of tablet in a single dose combination fasted
PF-07799933 film-coated tablets with PF-07799544 fasted
Participants receive Form 2 in a single dose of tablet in a single dose combination fasted
PF-07799933 film-coated tablets with PF-07799544 fed
Participants receive Form 2 in a single dose of tablet in a single dose combination in the fed state
PF-07799933 film-coated tablets fasted
Participants receive Form 2 in a single dose of tablet fasted
PF-07799933 film-coated tablets following rabeprazole pretreatment fasted
Participants receive Form 2 in a single dose of tablet following rabeprazole pre-treatment fasted
Locations (1)
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States