💬In plain words
What the trial is, and whether it could suit you
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 st
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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