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

Last updated: May 11, 2026
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

1

Condition

Kidney Failure (Pediatric)

Renal Failure

Kidney Failure

Treatment

PF-07328948

Clinical Study ID

NCT07315360
C4921014
C4921014
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to learn how the study medicine PF-07328948 is processed by the body and how safe and tolerable it is in adults with different levels of kidney function.

The study will include participants who:

  • Are aged 18 to 80 years.

  • Either have normal kidney function or long-term reduced kidney function (moderate or severe).

  • Have a BMI (body mass index) of 17.5 to 40 kilogram per meter squared, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds.

All participants will receive a single dose of PF-07328948 as a tablet taken by mouth. Participants will stay at a clinical research unit for about 6 days to receive the study medicine and undergo safety checks. Total participation lasts up to 64 days, including screening, inpatient stay, and a follow-up call.

The study is not randomized or blinded, meaning all participants and study staff know which treatment is being given. Group assignment is based on kidney function tests done during screening. The results will help researchers understand how reduced kidney function affects the way PF-07328948 works in the body.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female of nonchildbearing potential, between the ages of 18 and 80 years, atthe 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 adetailed medical history, physical exam, including blood pressure and pulse ratemeasurement, ECG and clinical laboratory tests.

  • Group 1 only: normal renal function (mean eGFR ≥90 mL/min) based on an average ofmeasures from the screening visits.

  • Groups 2 & 3 only: good general health considered acceptable with the expectedhealth status of individuals with chronic renal impairment.

  • Groups 2 & 3 only: chronic renal impairment, defined by the following mean eGFRcriteria (based on screening visits):

  • Severe RI: 15 ≤ mean eGFR <30 mL/min, not requiring hemodialysis.

  • Moderate RI: 30 ≤ mean eGFR <60 mL/min.

Exclusion

Exclusion Criteria:

  • 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 studyclinic.

  • 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 bloodpressure ≥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 QRSinterval >120 ms.

  • Groups 2 & 3 only: unstable medical conditions or comorbidities that would interferewith study participation

Study Design

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: PF-07328948
Phase: 1
Study Start date:
January 28, 2026
Estimated Completion Date:
March 13, 2027

Connect with a study center

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Active - Recruiting

  • Orange County Research Center

    Lake Forest 5364514, California 5332921 92630
    United States

    Site Not Available

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • Genesis Clinical Research, LLC

    Tampa, Florida 33603
    United States

    Active - Recruiting

  • Orlando Clinical Research Center

    Orlando 4167147, Florida 4155751 32809
    United States

    Site Not Available

  • Genesis Clinical Research, LLC

    Tampa 4174757, Florida 4155751 33603
    United States

    Site Not Available

  • Nucleus Network

    Saint Paul, Minnesota 55114
    United States

    Active - Recruiting

  • Nucleus Network

    Saint Paul 5045360, Minnesota 5037779 55114
    United States

    Site Not Available

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