PF-08049820 for Healthy Adults

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18 or older, with a body mass index between 16 and 32, and weighing more than 110 pounds. Participants should not have any significant health problems.

Inclusion Criteria

Body mass index (BMI) of 16-32 kg/m2 and a total body weight greater than 50kg (110 lb)

I am 18 years old or older.

I am a healthy male or female.

Exclusion Criteria

Evidence or history of clinically significant medical conditions

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants take three forms of study medicine, one after the other, with or without food for a total of five doses. Each dose is separated by a few days.

2 weeks

In-clinic stay

Follow-up Part A

Participants receive a telephone follow-up call about a month after the last dose.

4 weeks

1 visit (telephone)

Treatment Part B (Optional)

Participants take three forms of study medicine with or without food, and with or without rabeprazole, for a total of six doses. Each dose is separated by a few days.

3 weeks

In-clinic stay

Follow-up Part B (Optional)

Participants receive a follow-up phone call about a month after the last dose.

4 weeks

1 visit (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• PF-08049820
• Rabeprazole

Trial Overview

The study tests how different forms of the medicine PF-08049820 are absorbed in the body when taken with or without food, and also when combined with rabeprazole (a stomach acid reducer). The study has two parts involving several doses over a few weeks.

How Is the Trial Designed?

Group I: Sequence 7 (Optional Part B) Experimental Treatment 2 Interventions

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

Group II: Sequence 6 (Part A) Experimental Treatment 1 Intervention

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

Group III: Sequence 5 (Part A) Experimental Treatment 1 Intervention

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

Group IV: Sequence 4 (Part A) Experimental Treatment 1 Intervention

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

Group V: Sequence 3 (Part A) Experimental Treatment 1 Intervention

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

Group VI: Sequence 2 (Part A) Experimental Treatment 1 Intervention

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

Group VII: Sequence 1 (Part A) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University