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NCT Number: NCT07597928

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

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).

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Key information

Conditions

Healthy Adults Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-08049820

Drug

Administered orally

rabeprazole

Drug

Administered orally

Primary outcomes

  1. 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

    Part A: Evaluate the relative bioavailability of different formulations of PF-08049820.

    Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.

  2. 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

    Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820.

    Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.

  3. Maximum observed plasma concentration (Cmax)

    Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B

    Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820.

    Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.

Secondary outcomes

  1. 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

    Part A and optional Part B

  2. 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

    Part A and optional Part B

  3. 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

    Part A and optional Part B

  4. 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

    Part A and optional Part B

  5. 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

    Part A and optional Part B

  6. 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

    Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.

  7. 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

    Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.

  8. Maximum observed plasma concentration (Cmax)

    Time frame: Baseline up to Day 16 for Part A

    Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 20, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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