Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07563894

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

Led by Pfizer · Updated on 2026-05-04

16

Participants Needed

1

Research Sites

10 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants of non-childbearing potential and male participants aged 18 to 65 years
  • Overtly healthy as determined by medical evaluation including medical history, physical exam, lab tests, vital signs, and ECGs
  • Body mass index between 16 and 32 kg/m2
  • Total body weight over 50 kg (110 lb)
Not Eligible

You will not qualify if you...

  • History or evidence of significant uveitis, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except untreated, asymptomatic seasonal allergies at dosing)
  • Any condition affecting drug absorption such as gastrectomy, cholecystectomy, chronic diarrhea, or inflammatory bowel disease
  • History of HIV, hepatitis B or C infection
  • History or risk factors for retinal vein occlusion or retinal degenerative disease, or blurred vision
  • Active bacterial, fungal, or viral infection
  • Major surgery within 2 weeks before starting study treatment
  • Known or suspected hypersensitivity to study drug or its ingredients
  • Any medical or psychiatric condition or lab abnormality increasing study risk or making participation inappropriate
  • Use of drugs or supplements within 7 days or 5 half-lives before first study dose; prior use of proton pump inhibitors within 7 days not allowed
  • Use of medications that strongly or moderately affect certain liver enzymes or metabolism within specified periods before dosing
  • Current use or unwillingness to use required concomitant medications
  • Prior investigational drug or vaccine use within 30 days or 5 half-lives before first study dose
  • Positive urine drug test (single repeat allowed)
  • Use of tobacco or nicotine products within 3 months of screening or positive urine cotinine test
  • Screening blood pressure above defined age-specific limits after rest
  • Estimated glomerular filtration rate below 60 mL/min/1.73 m2
  • Abnormal ECG findings that may affect safety or study interpretation
  • Certain abnormal lab test results at screening, confirmed if needed
  • History of alcohol abuse, repeated binge drinking, or illicit drug use within 6 months of screening

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, United States, 06511

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

5

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