A Phase 1 interventional study of PF-07293893 and Placebo in Healthy Participants, sponsored by Pfizer. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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:
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Healthy adult participants will receive a single dose of PF-07293893 or placebo
Drug: PF-07293893 · Drug: Placebo
Healthy adult participants will receive a single dose of PF-07293893 or placebo
Drug: PF-07293893 · Drug: Placebo
A single dose of PF-07293893 administered orally as tablets
A single dose of Placebo administered orally as tablets that look the same as PF-07293893
Change from baseline of skeletal muscle pACC/tACC ratio
Time frame: Day 1 Pre-dose and 2 & 4 hours Post-dose
Number of Participants with Treatment Related Adverse Events (AEs)
Time frame: Baseline through Day 36
Number of Participants with change from Baseline in Laboratory Test Results
Time frame: Baseline through Day 36
Number of Participants with Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline through Day 36
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
Number of Participants With Change From Baseline in Physical Examinations
Time frame: Baseline through Day 36
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
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
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
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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