PF-07328948 for Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how different levels of liver function affect the body's processing of a new potential drug, PF-07328948. It examines individuals with varying degrees of liver impairment and those without liver issues to determine if their bodies handle the treatment differently. Participants will take the medicine in tablet form and stay at the clinic for about six days for monitoring. The study seeks individuals with stable liver impairment or no liver issues who meet specific health criteria. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop taking my current medications for the trial?
If you are in Groups 1, 2, or 3, you need to be on stable medications for your liver condition, so you may not need to stop them. However, the trial does mention some prohibited therapies, so it's best to discuss your specific medications with the study team.
Is there any evidence suggesting that PF-07328948 is likely to be safe for humans?
Research has shown that PF-07328948 is being tested for safety and effects in various conditions, including heart failure. In one heart failure study, researchers administered the treatment in low, medium, and high doses to assess its safety and effects in the body.
Although detailed safety data is not available here, it is important to note that this trial is in an early stage. The primary goal is to evaluate the treatment's safety and tolerability. So far, studies have not reported any major safety concerns. However, as this is a new treatment, unknown risks may exist, making careful monitoring during the trial essential.
Prospective participants should discuss any concerns with the study team. They can provide more information on what to expect and how they ensure participant safety.12345Why do researchers think this study treatment might be promising for liver disease?
Unlike current treatments for liver disease, which often involve complex regimens and sometimes invasive procedures, PF-07328948 is a promising new drug that offers a straightforward approach with its oral tablet form. Researchers are excited because it targets liver disease directly, potentially simplifying treatment for patients with varying degrees of hepatic impairment. This could mean easier, more accessible care for those affected, with the convenience of a single-dose tablet making it a standout option compared to existing therapies.
What evidence suggests that this trial's treatment, PF-07328948, could be effective for liver disease?
Research has shown that PF-07328948 is a promising treatment. Originally developed to target the enzyme BDK, which is involved in metabolism, early studies found PF-07328948 to be safe, well-tolerated, and well-absorbed. Tests on individuals with heart failure have shown potential in managing symptoms. Although direct data on its effects on liver disease is limited, the drug's mechanism suggests it could be beneficial by influencing metabolic processes. The current trial includes participants with varying degrees of hepatic impairment and those without impairment to understand how liver function affects the drug's processing. This is crucial for determining its potential benefits for liver disease.12346
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 adults aged 18-75 with stable liver impairment (Child-Pugh Class A, B, or C) or healthy individuals without liver issues. Participants must have a BMI of 17.5 to 40 kg/m2 and weigh at least 45 kg (99 lbs). They should be able to follow the study plan and not be of childbearing potential.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of PF-07328948 and stay onsite for about 6 days for monitoring and blood sampling
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PF-07328948
Trial Overview
The study tests how PF-07328948 is processed in bodies with varying levels of liver function. Participants will take a single dose of the medicine in tablet form and stay at the clinic for about six days for monitoring and blood tests to measure drug levels.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants without hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Participants with mild hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Participants with moderate hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Participants with severe hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
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
NCT06991257 | A Study to Learn About the ...
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 Protocol C4921001 Final ...
The purpose of the study is to evaluate the safety, tolerability, plasma PK and PD of PF-07328948 following administration of escalating, single ...
PF-07328948 for Heart Failure
The trial aims to assess the medicine's effectiveness and safety for individuals with heart failure. It is suitable for those who have experienced heart failure ...
4.
semanticscholar.org
semanticscholar.org/paper/Discovery-of-First-Branched-Chain-Ketoacid-Kinase-Filipski-Mart%C3%ADnez-Alsina/bc4ddc27168930b69850d08c2ade8fd1d488a6aaDiscovery of First Branched-Chain Ketoacid Dehydrogenase ...
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 ...
5.
cdn.pfizer.com
cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_30JAN2024_0.pdf?VersionId=rV_MQ9a_j2LPoLQGzWI5Pp9ciQ1JLp1iPfizer Pipeline
Data available to support the request for eligibility should support the claim to address the unmet medical need through a clinically meaningful ...
6.
researchgate.net
researchgate.net/publication/385945896_Discovery_of_First_Branched-Chain_Ketoacid_Dehydrogenase_Kinase_BDK_Inhibitor_Clinical_Candidate_PF-07328948Discovery of First Branched-Chain Ketoacid ...
Discovery of First Branched-Chain Ketoacid Dehydrogenase Kinase (BDK) Inhibitor Clinical Candidate PF-07328948. November 2024; Journal of Medicinal Chemistry 68 ...
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