Phase
Condition
Kidney Failure (Pediatric)
Renal Failure
Kidney Failure
Treatment
PF-07328948
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Orange County Research Center
Lake Forest, California 92630
United StatesActive - Recruiting
Orange County Research Center
Lake Forest 5364514, California 5332921 92630
United StatesSite Not Available
Orlando Clinical Research Center
Orlando, Florida 32809
United StatesActive - Recruiting
Genesis Clinical Research, LLC
Tampa, Florida 33603
United StatesActive - Recruiting
Orlando Clinical Research Center
Orlando 4167147, Florida 4155751 32809
United StatesSite Not Available
Genesis Clinical Research, LLC
Tampa 4174757, Florida 4155751 33603
United StatesSite Not Available
Nucleus Network
Saint Paul, Minnesota 55114
United StatesActive - Recruiting
Nucleus Network
Saint Paul 5045360, Minnesota 5037779 55114
United StatesSite Not Available

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