A STUDY TO LEARN HOW THE STUDY MEDICINE CALLED PF-07293893 AFFECTS MUSCLE BIOMARKERS OF HEALTHY ADULTS

NCT ID: NCT06413693

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2024-08-05

Brief Summary

The purpose of this study is to understand how the study medicine (PF-07293893) affects muscle biomarkers. Biomarkers are like clues or signs in our body that can help doctors understand our health. PF-07293893 is being studied as a possible treatment for people with heart disease who have reduced ability to exercise. This study aims to see how the study medicine affects muscle biomarkers related to the ability to exercise.

This study is seeking participants who:

1. Are males 18 to 65 years of age and females who are not able to become pregnant;

2. Have body mass index of 16 to 32 kilograms per meter square and a total body weight of more than 50 kilograms (110 pounds);

3. Over prior 4 weeks have an average of less than:

-150 minutes of moderate-intensity aerobic physical activity throughout each week. Moderate-intensity physical activity feels somewhat hard. Your breathing becomes faster, but you are not out of breath. You can hold a conversation, but you cannot sing.

AND

-75 minutes of vigorous-intensity aerobic physical activity throughout each week. Vigorous-intensity physical activity feels challenging. You are breathing fast and deep. You cannot say more than a few words without pausing.

OR

-An equivalent combination of moderate-and vigorous-intensity activity.

Participants will stay at the study clinic for about four days. On the third day, participants will take the study medicine or placebo (dummy pill) by mouth once at the study clinic and then stay at the study clinic for another day. During this time, the study team will check the treatment and take some blood and muscle tissue samples from the leg. This will help to understand if the study medicine affects muscle biomarkers. Participants will return to the study clinic for a follow-up visit or receive a follow-up telephone call about a month later.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cohort 1

Healthy adult participants will receive a single dose of PF-07293893 or placebo

Group Type: EXPERIMENTAL

PF-07293893

Intervention Type: DRUG

A single dose of PF-07293893 administered orally as tablets

Placebo

Intervention Type: DRUG

A single dose of Placebo administered orally as tablets that look the same as PF-07293893

Optional Cohort 2

Healthy adult participants will receive a single dose of PF-07293893 or placebo

Group Type: EXPERIMENTAL

PF-07293893

Intervention Type: DRUG

A single dose of PF-07293893 administered orally as tablets

Placebo

Intervention Type: DRUG

A single dose of Placebo administered orally as tablets that look the same as PF-07293893

Interventions

PF-07293893

A single dose of PF-07293893 administered orally as tablets

Intervention Type: DRUG

Placebo

A single dose of Placebo administered orally as tablets that look the same as PF-07293893

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males 18 to 65 years of age and females of non-childbearing potential;

2. Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg (110 lb);

3. Over prior 4 weeks an average of less than 150 minutes of moderate-intensity aerobic physical activity throughout each week, and less than 75 minutes of vigorous-intensity aerobic physical activity throughout each week, or an equivalent combination of moderate- and vigorous-intensity activity.

Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease;

2. History of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C;

3. Kidney impairment as defined by an estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m²;

4. A positive urine drug test;

5. Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Research Centers of America ( Hollywood )

Hollywood, Florida, United States

Research Centers of America

Hollywood, Florida, United States

Countries

United States

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C5171004

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

Other Identifiers

C5171004

Identifier Type: -

Identifier Source: org_study_id