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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.