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

NCT ID: NCT06327880

Last Updated: 2024-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-13

Study Completion Date

2024-07-02

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-07054894

Group Type EXPERIMENTAL

PF-07054894 or placebo

Intervention Type DRUG

multiple oral doses of PF-07054894 for 14 days

Placebo

Group Type PLACEBO_COMPARATOR

PF-07054894 or placebo

Intervention Type DRUG

multiple oral doses of PF-07054894 for 14 days

Interventions

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PF-07054894 or placebo

multiple oral doses of PF-07054894 for 14 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, Belgium

Site Status

Countries

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Belgium

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4151006

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

Other Identifiers

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2023-509339-17-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

C4151006

Identifier Type: -

Identifier Source: org_study_id

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