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A STUDY TO LEARN HOW THE STUDY MEDICINE CALLED PF-07293893 AFFECTS MUSCLE BIOMARKERS OF HEALTHY ADULTS - Trial NCT06413693

Access comprehensive clinical trial information for NCT06413693 through Pure Global AI's free database. This Phase 1 trial is sponsored by Pfizer and is currently Not yet recruiting. The study focuses on Healthy Participants. Target enrollment is 60 participants.

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NCT06413693
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06413693
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A STUDY TO LEARN HOW THE STUDY MEDICINE CALLED PF-07293893 AFFECTS MUSCLE BIOMARKERS OF HEALTHY ADULTS
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

Study Focus

Healthy Participants

PF-07293893

Interventional

drug

Sponsor & Location

Pfizer

Timeline & Enrollment

Phase 1

May 26, 2024

Oct 07, 2024

60 participants

Primary Outcome

Change from baseline of skeletal muscle pACC/tACC ratio

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.

ICD-10 Classifications

Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmful
Healthy person accompanying sick person
Routine general health check-up of sports teams
Obesity
Persons with potential health hazards related to communicable diseases

Data Source

ClinicalTrials.gov

NCT06413693

Non-Device Trial