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Completed

NCT Number: NCT06413693

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Centers of America, Hollywood, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PF-07293893

Drug

A single dose of PF-07293893 administered orally as tablets

Placebo

Drug

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

Primary outcomes

  1. Change from baseline of skeletal muscle pACC/tACC ratio

    Time frame: Day 1 Pre-dose and 2 & 4 hours Post-dose

Secondary outcomes

  1. Number of Participants with Treatment Related Adverse Events (AEs)

    Time frame: Baseline through Day 36

  2. Number of Participants with change from Baseline in Laboratory Test Results

    Time frame: Baseline through Day 36

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

    Time frame: Baseline through Day 36

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

    Time frame: Baseline and Day 1 Pre-dose and 6 hours Post-dose

  5. Number of Participants With Change From Baseline in Physical Examinations

    Time frame: Baseline through Day 36

  6. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2

  7. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2

  8. Area under the serum concentration vs. time curve for 0-24 hours (AUC24)

    Time frame: Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, DOUBLE-BLIND (SPONSOR-OPEN) PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECT OF PF-07293893 ON SKELETAL MUSCLE BIOMARKERS IN HEALTHY ADULT PARTICIPANTS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 14, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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