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PF-07328948 for Healthy Subjects

Age: 18 - 65
Sex: Male
Trial Phase: Phase 1
Sponsor: Pfizer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the experimental drug PF-07328948 enters and exits the body. Researchers test both oral and injection methods to observe the drug's absorption and elimination. The study consists of two parts: the first part examines basic absorption, while the optional second part investigates the effects of daily dosing. Healthy men within specific body weight and BMI ranges are invited to participate. Participants will provide blood and urine samples, and researchers will closely monitor their safety throughout the study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that taking other medications might not be allowed. Please check with the study team for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PF-07328948 has been studied for its safety and effects. Early studies with healthy adults found that participants generally tolerated the treatment well. While researchers monitored some unwanted effects, they did not commonly report serious problems. Other studies focused on heart health and found that the treatment posed a low risk of unexpected reactions. Importantly, PF-07328948 exits the body quickly, which can help reduce the risk of side effects. Overall, early findings suggest that PF-07328948 is safe for people, but further research is ongoing to confirm this.12345

Why are researchers excited about this trial's treatments?

PF-07328948 is unique because it employs a novel approach by using a radiolabeled compound, [14C]PF-07328948, to understand the drug's metabolism and distribution in the body. Unlike standard oral medications, this treatment includes a combination of oral doses and intravenous infusions, which can provide more detailed information about how the drug behaves in the body. Researchers are excited about this treatment because it could lead to more precise dosing and improved safety profiles, making it potentially more effective and safer than existing treatments.

What evidence suggests that PF-07328948 could be effective for healthy subjects?

Research has shown that PF-07328948 is a new drug targeting a protein involved in metabolism. Early studies suggest it may improve heart failure by enhancing nutrient processing in the body. Initial data indicate that PF-07328948 is generally safe and well-tolerated in healthy adults. In this trial, participants will receive different formulations and dosages of PF-07328948 to further assess its safety and metabolic effects. Although still under investigation, these findings suggest potential benefits for heart-related issues. More research is needed to fully understand its effectiveness, but early results are promising.26789

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy men aged 18 to 64 years, with a BMI between 17.5 and 32, and weighing over 110 pounds. Participants must pass medical checks including physical exams, lab tests, and heart monitoring.

Inclusion Criteria

I am a healthy male between 18 and 64 years old.
My BMI is between 17.5 and 32, and I weigh more than 110 pounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Period 1

The purpose is to see how much of the study medicine PF-07328948 gets into and leaves the body.

Approximately 2 weeks
Multiple visits for sample collection and safety reviews

Period 2

Compare how much PF-07328948 is available in the body when taken by mouth versus by injection into the blood.

Approximately 2 weeks
Multiple visits for sample collection and safety reviews

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Period 3 (Optional)

Assess how PF-07328948 acts after taking it daily until the body reaches a steady level.

9 days to 1 month
Daily dosing with regular monitoring

Period 4 (Optional)

Check again how much PF-07328948 is absorbed and leaves the body after daily dosing.

Approximately 1 month
Daily dosing with regular monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • PF-07328948

Trial Overview

The study is testing how the medicine PF-07328948 is absorbed and removed from the body when taken by mouth or injected into the blood. It involves several periods of dosing and sample collection to compare different ways of giving the drug.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Period 4/Treatment DExperimental Treatment1 Intervention
Group II: Period 3/Treatment CExperimental Treatment1 Intervention
Group III: Period 2/Treatment BExperimental Treatment2 Interventions
Group IV: Period 1/Treatment AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

NCT05807490 | A Study to Learn How Different Amounts of ...

The purpose of Part A of this study is to learn about the safety, tolerability, and how PF-07328948 is processed by the body when multiple doses of PF-07328948 ...

PF-07328948 Protocol C4921001 Final ...

Study C4921001 is the first time that PF-07328948 will be administered to humans and is designed primarily to generate safety, tolerability, and ...

A Study to Learn About the Study Medicine Called ... - MedPath

The study determines if the study medicine (PF-07328948) is safe and effective compared to placebo in people with heart failure who are already taking standard- ...

PF-07328948: A Potential Breakthrough in Treating Heart ...

PF-07328948 is a small molecule drug developed by Pfizer Inc. The drug targets BCKDK and falls within the therapeutic area of cardiovascular diseases.

Clinical Study Results

The main purpose of this study was to evaluate the safety and tolerability of increasing doses of PF-07328948 when given to healthy adult ...

Safety Data Sheet

PF-07328948. Catalog No. : HY-159648. CAS No. : 2936625-34-0. 1.2 ... Identified uses : Laboratory chemicals, manufacture of substances. 1.3 ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39560668/

Discovery of First Branched-Chain Ketoacid ...

PF-07328948 is the first known selective BDK inhibitor candidate to be examined in clinical studies, with Phase 1 single ascending dose data showing good ...

PF-07328948 for Heart Failure

The purpose of this study is to learn about the safety and effects of the study medicine (PF-07328948) for the possible treatment of heart failure (HF). 3 ...

Pfizer presents data on PF-07328948 for the treatment of ...

Additionally, PF-07328948 demonstrated lower covalent binding, decreasing the risk of idiosyncratic adverse drug reactions. Its half-life in ...