Clinical trial NCT06413693: A STUDY TO LEARN HOW THE STUDY MEDICINE CALLED PF-07293893 AFFECTS MUSCLE BIOMARKERS OF HEALTHY ADULTS
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Change from baseline of skeletal muscle pACC/tACC ratio
timeFrame: Day 1 Pre-dose and 2 & 4 hours Post-dose
Secondary outcomes:
measure: Number of Participants with Treatment Related Adverse Events (AEs)
timeFrame: Baseline through Day 36
measure: Number of Participants with change from Baseline in Laboratory Test Results
timeFrame: Baseline through Day 36
measure: Number of Participants with Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline through Day 36
measure: Number of Participants with Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)
timeFrame: Baseline and Day 1 Pre-dose and 6 hours Post-dose
measure: Number of Participants With Change From Baseline in Physical Examinations
timeFrame: Baseline through Day 36
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2
measure: Area under the serum concentration vs. time curve for 0-24 hours (AUC24)
timeFrame: Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood )
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: