PF-07328948 for Renal Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how the body processes a new medicine, PF-07328948, and evaluates its safety for people with varying kidney function levels. Participants will take a single pill and stay at a research center for about six days to monitor safety and effects. It suits adults with normal kidney function or those with moderate to severe kidney issues, who weigh at least 99 pounds. The goal is to determine how kidney function levels affect the medicine's action in the body. As a Phase 1 trial, this research aims to understand the treatment's effects in people, offering participants the chance to be among the first to receive this new medicine.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.
Is there any evidence suggesting that PF-07328948 is likely to be safe for humans?
Research has shown that PF-07328948 is in the early stages of testing to determine its safety for people. Scientists are examining its mechanism and how individuals with varying kidney functions process it. Since this is the first human trial of PF-07328948, detailed safety information is not yet available. Early studies typically focus on assessing how well participants tolerate the treatment and identifying any side effects.
Due to PF-07328948's early stage in clinical trials, limited safety information may be available. Participants in these studies receive close monitoring to ensure any side effects are promptly addressed. Those with concerns should consider discussing them with the study team to learn more about what to expect.12345Why do researchers think this study treatment might be promising for renal disease?
PF-07328948 is unique because it offers a potential new approach to treating renal disease, particularly for those with varying levels of kidney impairment. Unlike standard treatments that often focus on managing symptoms or slowing progression, PF-07328948 is being investigated for its ability to work effectively across different levels of renal function with a single, oral dose. Researchers are excited about this because it could simplify treatment regimens and improve patient outcomes by providing a consistent and convenient option for people with severe, moderate, or no renal impairment.
What evidence suggests that PF-07328948 might be an effective treatment for renal disease?
Researchers are studying how the medicine PF-07328948 works in people with reduced kidney function. Participants in this trial will be divided into groups based on their level of renal impairment: Group 1 includes those without renal impairment, Group 2 includes those with severe renal impairment, and Group 3 includes those with moderate renal impairment. Other studies on similar medicines have shown changes in how the body processes them in people with severe kidney issues. This suggests the medicine might act differently in people with kidney problems compared to those with normal kidney function. The study aims to determine if PF-07328948 is safe and effective by observing its effects in people with varying levels of kidney health. Early studies focus on safety and how the body handles the medicine, which is crucial for understanding its potential in treating kidney-related conditions.12367
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 18-80 with varying kidney function, from normal to severe reduction not requiring dialysis. Participants must have a stable renal function, BMI of 17.5-40 kg/m², and weigh at least 45 kg (99 lbs). Those with moderate or severe renal impairment should be in good general health.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of PF-07328948 and stay at a clinical research unit for safety checks
Follow-up
Participants are monitored for safety and effectiveness after treatment via a follow-up call
What Are the Treatments Tested in This Trial?
Interventions
- PF-07328948
Trial Overview
The study tests how the body processes PF-07328948 in individuals with different levels of kidney function. Everyone gets one dose of the medicine by mouth and stays at a research unit for about six days for monitoring. The study lasts up to 64 days including follow-up.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants with moderate renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Participants with severe renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Participants without renal 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
NCT07315360 | A Study to Learn How the Body Processes ...
The results will help researchers understand how reduced kidney function affects the way PF-07328948 works in the body. Official Title. A PHASE 1, OPEN-LABEL, ...
Clinical Trial for Renal Impairment and Healthy.
The results will help researchers understand how reduced kidney function affects the way PF-07328948 works in the body. View locations for this study. Find ...
A First-in-human Study of Single Doses of PF-07328948 ...
This study is the first clinical study with PF-07328948. The safety, tolerability, and plasma pharmacokinetics and pharmacodynamics of PF-07328948
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 ...
The effect of severe renal impairment on the pharmacokinetics ...
The total apparent balcinrenone clearance was 50% lower in the severe renal impairment group, resulting in an approximately two‐fold higher area under the curve ...
PF-07328948 - Drug Targets, Indications, Patents
A Clinically potential BDK inhibitor, PF-07328948, with excellent drug-like properties, is under phase-1 clinical trials for CVD metabolic disorders.
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ctv.veeva.com
ctv.veeva.com/study/a-first-in-human-study-of-single-doses-of-pf-07328948-which-is-given-to-healthy-adult-participantsA First-in-human Study of Single Doses of PF-07328948 ...
This study is the first clinical study with PF-07328948. The safety, tolerability, and plasma pharmacokinetics and pharmacodynamics of PF-07328948
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