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

NCT06413693 | Completed Phase 1 FDA Drug

• 1 other identifier: C5171004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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:

• 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline of skeletal muscle pACC/tACC ratio

  Day 1 Pre-dose and 2 & 4 hours Post-dose

Secondary Outcomes (8)

• Number of Participants with Treatment Related Adverse Events (AEs)

  Baseline through Day 36

• Number of Participants with change from Baseline in Laboratory Test Results

  Baseline through Day 36

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

  Baseline through Day 36

• Number of Participants with Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)

  Baseline and Day 1 Pre-dose and 6 hours Post-dose

• Number of Participants With Change From Baseline in Physical Examinations

  Baseline through Day 36

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: PF-07293893; Drug: Placebo

Optional Cohort 2

EXPERIMENTAL

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

Drug: PF-07293893; Drug: Placebo

Interventions

PF-07293893 DRUG

A single dose of PF-07293893 administered orally as tablets

Cohort 1; Optional Cohort 2

Placebo DRUG

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

Cohort 1; Optional Cohort 2

Eligibility Criteria

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

You may qualify if:

• Males 18 to 65 years of age and females of non-childbearing potential;
• Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg (110 lb);
• 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.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease;
• History of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C;
• Kidney impairment as defined by an estimated glomerular filtration rate (eGFR) \<75 mL/min/1.73 m²;
• A positive urine drug test;
• Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: May 23, 2024
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)