Healthy ParticipantsPhase 1NCT06413693
A STUDY TO LEARN HOW THE STUDY MEDICINE CALLED PF-07293893 AFFECTS MUSCLE BIOMARKERS OF HEALTHY ADULTS
A Phase 1 study testing PF-07293893 in people with Healthy Participants, run by Pfizer at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- PF-07293893
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 May 2024to 5 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males 18 to 65 years of age and females of non-childbearing potential;
- Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg (110 lb);
- 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.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease;
- History of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C;
- Kidney impairment as defined by an estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m²;
- A positive urine drug test;
- Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
Research Centers of America
Hollywood, Florida, 33024
About this study
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
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:
- Are males 18 to 65 years of age and females who are not able to become pregnant;
- Have body mass index of 16 to 32 kilograms per meter square and a total body weight of more than 50 kilograms (110 pounds);
- 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
- Healthy Participants
- Being tested
- PF-07293893, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07293893Drug
A single dose of PF-07293893 administered orally as tablets
PlaceboDrug
A single dose of Placebo administered orally as tablets that look the same as PF-07293893
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Healthy adult participants will receive a single dose of PF-07293893 or placebo Receives: Drug: PF-07293893; Drug: Placebo |
| Optional Cohort 2 | Experimental | Healthy adult participants will receive a single dose of PF-07293893 or placebo Receives: Drug: PF-07293893; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of skeletal muscle pACC/tACC ratio
Measured: Day 1 Pre-dose and 2 & 4 hours Post-dose
Secondary outcomes (8)
Number of Participants with Treatment Related Adverse Events (AEs)
Measured: Baseline through Day 36
Number of Participants with change from Baseline in Laboratory Test Results
Measured: Baseline through Day 36
Number of Participants with Clinically Significant Change From Baseline in Vital Signs
Measured: Baseline through Day 36
Number of Participants with Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)
Measured: Baseline and Day 1 Pre-dose and 6 hours Post-dose
Number of Participants With Change From Baseline in Physical Examinations
Measured: Baseline through Day 36
Maximum Observed Plasma Concentration (Cmax)
Measured: 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)
Measured: 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)
Measured: Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start23 May 2024
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413693
- Sponsor's protocol ID
- C5171004
- Status last verified
- Nov 2024
- First submitted
- 9 May 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06413693
- Acronym / sponsor ID
- C5171004
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 23 May 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are males 18 to 65 years of age and females who are not able to become pregnant;
- Have body mass index of 16 to 32 kilograms per meter square and a total body weight of more than 50 kilograms (110 pounds);
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF-07293893, Drug: PlaceboHealthy adult participants will receive a single dose of PF-07293893 or placebo |
| Optional Cohort 2 | Experimental | Drug: PF-07293893, Drug: PlaceboHealthy adult participants will receive a single dose of PF-07293893 or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males 18 to 65 years of age and females of non-childbearing potential;
- Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg (110 lb);
- 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.
Key exclusion criteria (5 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease;
- History of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C;
- Kidney impairment as defined by an estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m²;
- A positive urine drug test;
- Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07293893A single dose of PF-07293893 administered orally as tablets | Drug | Cohort 1, Optional Cohort 2 |
| PlaceboA single dose of Placebo administered orally as tablets that look the same as PF-07293893 | Drug | Cohort 1, Optional Cohort 2 |
Primary outcome
Change from baseline of skeletal muscle pACC/tACC ratio
Time frame: Day 1 Pre-dose and 2 & 4 hours Post-dose
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07293893 in people with Healthy Participants, run by Pfizer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of skeletal muscle pACC/tACC ratio (time frame: Day 1 Pre-dose and 2 & 4 hours Post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024; AzTrials last refreshed its copy on 29 Oct 2026.