A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPfizer
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PF-07328948
DrugPF-07328948 , 1 tablet orally, once on Day 1
Treatment groups
28 Participants
are divided into 3 treatment groupsGroup A: Group 1: PF-07328948 participants without renal impairmentExperimental treatment 1 intervention
Group B: Group 2: PF-07328948 participants with severe renal impairmentExperimental treatment 1 intervention
Group C: Group 3: PF-07328948 participants with moderate renal impairmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
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 12
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.
Time frame
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 13
Unbound Cmax (Cmax,u) of PF-07328948
Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax.
Time frame
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 1Secondary outcomes
1
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame
Day 1 to Day 36 Source ClinicalTrials.gov