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

NCT07315360 | Recruiting Phase 1 FDA Drug

• 1 other identifier: C4921014
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Renal Impairment; Healthy

Keywords

Healthy Volunteers; Renal Impairment

Outcome Measures

Primary Outcomes (3)

• Fraction of Unbound Drug in Plasma (Fu) of PF-07328948

  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).

  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

• Unbound AUCinf (AUCinf,u) of PF-07328948

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

  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

• Unbound Cmax (Cmax,u) of PF-07328948

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

  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

Secondary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs)

  Day 1 to Day 36

Study Arms (3)

Group 1: PF-07328948 participants without renal impairment

EXPERIMENTAL

Participants without renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.

Drug: PF-07328948

Group 2: PF-07328948 participants with severe renal impairment

EXPERIMENTAL

Participants with severe renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.

Drug: PF-07328948

Group 3: PF-07328948 participants with moderate renal impairment

EXPERIMENTAL

Participants with moderate renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.

Drug: PF-07328948

Interventions

PF-07328948 DRUG

PF-07328948 , 1 tablet orally, once on Day 1

Group 1: PF-07328948 participants without renal impairment; Group 2: PF-07328948 participants with severe renal impairment; Group 3: PF-07328948 participants with moderate renal impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Orange County Research Center

Lake Forest, California, 92630, United States

RECRUITING

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

Genesis Clinical Research, LLC

Tampa, Florida, 33603, United States

RECRUITING

Nucleus Network

Saint Paul, Minnesota, 55114, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): March 13, 2027
• Study Completion (Estimated): March 13, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)