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Study of PF-07328948 in People with Reduced Kidney Function

This study aims to understand how your body processes the medicine PF-07328948 and to check its safety and how well it's tolerated in adults with different levels of kidney function. We are looking for 28 participants, aged 18 to 80, who have either normal kidney function or long-term reduced kidney function (moderate or severe). You would also need a body mass index (BMI) between 17.5 and 40.0 kg/m2 and weigh at least 99 pounds. All participants will receive a single tablet of PF-07328948 by mouth. The study will measure how much of the medicine is in your blood over time to understand how it's handled by your body. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 28 participants. It will involve giving a single dose of PF-07328948 to participants.
What's involved
You would stay at a clinical research unit for about 6 days to receive the study medicine and undergo safety checks.
Compensation
Not stated in the trial record.
Follow-up
Blood samples will be collected for up to 120 hours (5 days) after receiving the dose to measure the medicine's levels.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07315360

A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function

Recruiting
PHASE1Ages 18–80InterventionalBasic science
Pfizer
~28 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:PF-07328948

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fraction of Unbound Drug in Plasma (Fu) of PF-07328948
Measured over At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1
+2 more outcomes measured

Conditions

Renal Impairment
Healthy

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HealthyRenal Impairment

Where it's being run

4 sites across 3 states
Florida2
California1
Minnesota1

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female of nonchildbearing potential, between the ages of 18 and 80 years, at the screening visit.
BMI of 17.5 to 40.0 kg/m2 (inclusive), and a total body weight ≥45 kg (99 lbs).
Stable renal function, defined as ≤25% difference between 2 measurements of eGFR.
Group 1 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.
Group 1 only: normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from the screening visits.
Groups 2 \& 3 only: good general health considered acceptable with the expected health status of individuals with chronic renal impairment.
Groups 2 \& 3 only: chronic renal impairment, defined by the following mean eGFR criteria (based on screening visits):
Severe RI: 15 ≤ mean eGFR \<30 mL/min, not requiring hemodialysis.
Moderate RI: 30 ≤ mean eGFR \<60 mL/min.

Exclusion

Any condition possibly affecting drug absorption.
At screening, a positive result for HIV antibodies.
History of renal, liver, or heart transplantation.
Urinary incontinence without catheterization.
Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition.
Use of an investigational product within 30 days or 5 half-lives (whichever longer).
A positive urine drug test or breath alcohol test at screening or admission to study clinic.
Group 1 only: evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
Group 1 only: screening ECG demonstrating QTcF interval \>450 ms or a QRS interval \>120 ms.
Group 1 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg
Group 2 \& 3 only: presence of acute renal disease
Group 2 \& 3 only: requiring dialysis or anticipated need for dialysis
Group 2 \& 3 only: listed for solid organ transplantation
Groups 2 \& 3 only: persistent severe, uncontrolled hypertension at screening, admission to study clinic, or pre-dose on Day 1.
Groups 2 \& 3 only: screening ECG demonstrating a QTcF interval \>470 ms or a QRS interval \>120 ms.
Groups 2 \& 3 only: unstable medical conditions or comorbidities that would interfere with study participation

What this trial measures

  • Fraction of Unbound Drug in Plasma (Fu) of PF-07328948At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1

    Fu is the fraction of unbound drug in plasma, which is calculated by Cu/C (where Cu represents unbound concentration and C represents total concentration).

  • Unbound AUCinf (AUCinf,u) of PF-07328948At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1

    AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time. AUCinf,u is the unbound AUCinf.

  • Unbound Cmax (Cmax,u) of PF-07328948At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1

    Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax.