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

NCT07597928 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: C6231008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Are males or females,
2. 2.Are at least 18 years of age,
3. 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).

Conditions

Healthy Adults; Healthy

Outcome Measures

Primary Outcomes (3)

• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)

  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.

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

• Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit

  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.

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

• Maximum observed plasma concentration (Cmax)

  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.

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

Secondary Outcomes (8)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Baseline up to Day 48 for Part A and up to Day 56 for optional Part B

• Number of Participants With Serious Adverse Events (SAEs)

  Baseline up to Day 48 for Part A and up to Day 56 for optional Part B

• Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

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

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

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

• Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

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

Study Arms (7)

Sequence 1 (Part A)

EXPERIMENTAL

3 different formulations of PF-08049820 administered orally under fasted or fed conditions.

Drug: PF-08049820

Sequence 2 (Part A)

EXPERIMENTAL

3 different formulations of PF-08049820 administered orally under fasted or fed conditions.

Drug: PF-08049820

Sequence 3 (Part A)

EXPERIMENTAL

3 different formulations of PF-08049820 administered orally under fasted or fed conditions.

Drug: PF-08049820

Sequence 4 (Part A)

EXPERIMENTAL

3 different formulations of PF-08049820 administered orally under fasted or fed conditions.

Drug: PF-08049820

Sequence 5 (Part A)

EXPERIMENTAL

3 different formulations of PF-08049820 administered orally under fasted or fed conditions.

Drug: PF-08049820

Sequence 6 (Part A)

EXPERIMENTAL

3 different formulations of PF-08049820 administered orally under fasted or fed conditions.

Drug: PF-08049820

Sequence 7 (Optional Part B)

EXPERIMENTAL

3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions.

Drug: PF-08049820; Drug: Rabeprazole

Interventions

PF-08049820 DRUG

Administered orally

Sequence 1 (Part A); Sequence 2 (Part A); Sequence 3 (Part A); Sequence 4 (Part A); Sequence 5 (Part A); Sequence 6 (Part A); Sequence 7 (Optional Part B)

Rabeprazole DRUG

Administered orally

Sequence 7 (Optional Part B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 20, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)