## Protocol Section
### Identification Module
**NCT ID:** NCT06413693

**Brief Title:** 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

#### Organization Study ID Info
**ID:** C5171004
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
### Status Module
#### Completion Date
**Date:** 2024-10-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-26

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pfizer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy Participants

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Healthy adult participants will receive a single dose of PF-07293893 or placebo

**Intervention Names:**

- Drug: PF-07293893

- Drug: Placebo

**Label:** Cohort 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Healthy adult participants will receive a single dose of PF-07293893 or placebo

**Intervention Names:**

- Drug: PF-07293893

- Drug: Placebo

**Label:** Optional Cohort 2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cohort 1

- Optional Cohort 2

**Description:** A single dose of PF-07293893 administered orally as tablets

**Name:** PF-07293893

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Cohort 1

- Optional Cohort 2

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

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change from baseline of skeletal muscle pACC/tACC ratio

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

#### Secondary Outcomes

**Measure:** Number of Participants with Treatment Related Adverse Events (AEs)

**Time Frame:** Baseline through Day 36

**Measure:** Number of Participants with change from Baseline in Laboratory Test Results

**Time Frame:** Baseline through Day 36

**Measure:** Number of Participants with Clinically Significant Change From Baseline in Vital Signs

**Time Frame:** Baseline through Day 36

**Measure:** 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

**Measure:** Number of Participants With Change From Baseline in Physical Examinations

**Time Frame:** Baseline through Day 36

**Measure:** 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

**Measure:** 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

**Measure:** 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

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ClinicalTrials.gov_Inquiries@pfizer.com

**Name:** Pfizer CT.gov Call Center

**Phone:** 1-800-718-1021

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Pfizer

**Name:** Pfizer CT.gov Call Center

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** 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.

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** To obtain contact information for a study center near you, click here.

**URL:** https://pmiform.com/clinical-trial-info-request?StudyID=C5171004

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
