Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413693
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-09
Brief Title:
A STUDY TO LEARN HOW THE STUDY MEDICINE CALLED PF-07293893 AFFECTS MUSCLE BIOMARKERS OF HEALTHY ADULTS
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None