A Study to Learn if a Medicine That Reduces Stomach Acid Affects the Blood Level of Study Medicine PF-08049820 in Healthy Chinese Adults.

December 2, 2025 updated by: Pfizer

A Phase 1, Open Label, Fixed Sequence Study to Investigate the Effect of Rabeprazole on the Pharmacokinetics of PF-08049820 in Healthy Chinese Adult Participants.

This clinical study is designed to evaluate a study medicine called PF-08049820. The main aim is to understand how the body processes this medicine and whether giving it with another medicine, rabeprazole, affects how it behaves.

The study will take in healthy adult participants aged 18 to 65 years who are not able to have children. Eligible participants must weigh more than 50 kilograms (110 pounds) and have a Body Mass Index (BMI) between 18.5 and 27.9.

Each participant will receive two treatments:

  • One treatment with PF-08049820 alone
  • One treatment with PF-08049820 taken together with rabeprazole

Both medicines will be taken by mouth. Participants will stay at the study clinic for a few days during each treatment period. During these stays, the study team will collect blood samples to see how the body absorbs and processes the medicine.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100050
        • Beijing Friendship Hospital Affiliate of Capital University
      • Beijing, Beijing Municipality, China, 101100
        • Beijing Friendship Hospital Affiliate of Capital University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead electrocardiogram.
  • BMI of 18.5-27.9 kg/m2; and a total body weight >50 kg (110 lb).
  • Participants who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

  • History or evidence of significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic diseases.
  • Positive test for HIV, hepatitis B (HBsAg), or hepatitis C (HCVAb).
  • Active or latent tuberculosis (TB) infection or inadequate treatment history for TB.
  • Any medical or psychiatric condition, including active suicidal ideation in the past year or suicidal behavior in the past 5 years, that may increase risk or interfere with study participation.
  • Current use of prohibited medications or inability/unwillingness to use required medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
Participants will receive single oral dose of PF-08049820.
Oral tablets
Experimental: Treatment B
Participants will receive rabeprazole for 5 days followed by a single oral dose of PF-08049820 and rabeprazole.
Oral tablets
Other Names:
  • Pariet
Oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08049820.
Time Frame: Day 1 through Day 38-45
Day 1 through Day 38-45
PK: Area under the plasma concentration (AUC) of PF-08049820
Time Frame: Day 1 through Day 38-45
Day 1 through Day 38-45

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment emergent adverse events
Time Frame: First dose through Day 38-45
First dose through Day 38-45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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