A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-07054894 or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06327880

C4151006

2023-509339-17-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants.

The study is seeking the following participants:

• Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests.
• Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds).
• Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female Japanese subjects aged 18 years or older
• Body Mass Index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (100 lb)

Exclusion criteria

• Evidence or history of clinically significant disease or medical conditions
• Positive urine drug test or history of alcohol abuse or illicit drug use.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6 participants in 2 patient groups, including a placebo group

PF-07054894

Experimental group

Treatment:

Drug: PF-07054894 or placebo

Placebo

Placebo Comparator group

Treatment:

Drug: PF-07054894 or placebo