PF-07328948 for Healthy Subjects
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Period 1
The purpose is to see how much of the study medicine PF-07328948 gets into and leaves the body.
Period 2
Compare how much PF-07328948 is available in the body when taken by mouth versus by injection into the blood.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Period 3 (Optional)
Assess how PF-07328948 acts after taking it daily until the body reaches a steady level.
Period 4 (Optional)
Check again how much PF-07328948 is absorbed and leaves the body after daily dosing.
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
Participants will receive a single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 tablets
Participants will receive unlabeled tablet oral doses of PF-07328948 once daily for 9 days up to 1 month
Participants will receive a single tablet of unlabeled oral dose of PF-07328948; \~ 3 hours post-dose, participants will receive a single IV infusion of \[14C\]PF-07328948
Participants will receive a single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
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 ...
3.
trial.medpath.com
trial.medpath.com/clinical-trial/a2b1c352b29c88b8/nct06991257-pf-07328948-heart-failure-adults-studyA 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- ...
4.
synapse.patsnap.com
synapse.patsnap.com/blog/pf-07328948-a-potential-breakthrough-in-treating-heart-failure-with-normal-ejection-fractionPF-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 ...
6.
file.medchemexpress.com
file.medchemexpress.com/batch_PDF/HY-159648/PF-07328948-SDS-MedChemExpress.pdfSafety Data Sheet
PF-07328948. Catalog No. : HY-159648. CAS No. : 2936625-34-0. 1.2 ... Identified uses : Laboratory chemicals, manufacture of substances. 1.3 ...
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 ...
9.
bioworld.com
bioworld.com/articles/712146-pfizer-presents-data-on-pf-07328948-for-the-treatment-of-heart-failurePfizer 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 ...
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