Relative Bioavailability and Impact of Rabeprazole for PF-07799933, Food-Effect for PF-07799933 and PF-07799544

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Pfizer
Study ID
NCT07563894
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • PF-07799933 tablets with PF-07799544 fasted — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    Participants receive Form 2 in a single dose of tablet fasted
  • PF-07799933 film-coated tablets following rabeprazole pretreatment fasted — DRUG
    Participants receive Form 2 in a single dose of tablet following rabeprazole pre-treatment fasted

Study Details

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.

Key Dates

Start date
Apr 10, 2026
Status verified
May 2026
Primary completion
Jun 24, 2026
Completion
Jun 24, 2026

Study Design

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

Arms

  • Experimental: PF-07799933 Form 1 Tablet Arm with PF-07799544 Fasted
    Cohort 1 Period 1: Participants receive PF-07799933 tablets in Combination With PF-07799544
  • Experimental: PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 Fasted
    Cohort 1 Period 2: Participants receive PF-07799933 film-coated tablets in Combination With PF-07799544
  • Experimental: PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 under Fed Conditions
    Cohort 1 Period 3: Participants receive PF-07799933 film-coated tablets in Combination With PF-07799544 following a High-Fat Meal
  • Experimental: PF-07799933 Form 2 Tablet Arm
    Cohort 2 Period 1: Participants receive PF-07799933 film-coated tablets
  • Experimental: PF-07799933 Form 2 Tablet Arm following Rabeprazole Pretreatment
    Cohort 2 Period 1: Participants receive PF-07799933 film-coated tablets following rabeprazole treatment

Primary Outcome Measure

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pfizer Clinical Research Unit - New HavenNew HavenConnecticut06511-

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Pfizer Clinical Research Unit - New Haven· New Haven, CT

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