How the body processes PF-07328948 in people with normal or reduced kidney function

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF PF-07328948 IN ADULTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION

We will give a single oral dose of PF-07328948 to adults with normal or moderately-to-severely reduced kidney function to see how their bodies process the medicine and how well they tolerate it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Pfizer (Industry-sponsored)
• Locations: 4 sites (Lake Forest, California and 3 other locations)
• Trial ID: NCT07315360 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label study gives a single tablet dose of PF-07328948 to adults grouped by kidney function (normal, moderate impairment, severe impairment) and monitors drug levels and safety. Participants stay in a clinical research unit for about six days for dosing and intensive sampling, with overall participation lasting up to 64 days including screening and follow-up. Group assignment is based on measured eGFR values and the study is not randomized or blinded. Primary data will be pharmacokinetic measurements and tolerability/safety observations across the kidney-function groups.

Who should consider this trial

Good fit: Adults aged 18 to 80 with stable kidney function (normal or chronic moderate or severe impairment not requiring hemodialysis), BMI 17.5–40 kg/m2, weight ≥45 kg, and who are non-childbearing or of nonchildbearing potential are eligible.

Not a fit: People who are on hemodialysis, pregnant or of childbearing potential, have unstable renal function, or are outside the age/BMI/weight limits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If results are favorable, the data could guide safer and more appropriate dosing of PF-07328948 for people with reduced kidney function.

How similar studies have performed: Pharmacokinetic and safety studies in people with renal impairment are a standard, well-established approach and have been successfully used to adjust dosing for many drugs, though outcomes depend on each molecule.

Eligibility criteria

Inclusion Criteria:

* 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 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 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

Where this trial is running

Lake Forest, California and 3 other locations

• Orange County Research Center — Lake Forest, California, United States (Recruiting)
• Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
• Genesis Clinical Research, LLC — Tampa, Florida, United States (Recruiting)
• Nucleus Network — Saint Paul, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions Renal Impairment; Healthy; Healthy Volunteers