This study will characterize the effect of varying degrees of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF- 06882961 compared with participants with normal renal function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
42
PF-06882961 20 mg single oral dose provided in tablet form administered in a fed state on Day 1
University of Miami Hospital
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States
Maximum Observed Plasma Concentration (Cmax) of Plasma PF-06882961
Cmax was the maximum observed plasma concentration and was directly observed from data.
Time frame: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-06882961
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity.
Time frame: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-06882961
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.
Time frame: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3
Fraction Unbound (fu) of Plasma PF-06882961
Fu was defined as fraction of unbound drug in plasma.
Time frame: 0 (pre dose), 4 hours (post dose) on Day 1
Maximum Observed Concentration of Unbound Drug (Cmax,u) of Plasma PF-06882961
Cmax,u was defined as maximum observed concentration of unbound drug.
Time frame: 0 (pre dose), 4 hours (post dose) on Day 1
Unbound Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf,u) of Plasma PF-06882961
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AUCinf,u was defined as unbound area under the plasma concentration-time profile from time zero extrapolated to infinite time.
Time frame: 0 (pre dose), 4 hours (post dose) on Day 1
Unbound Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast,u) of Plasma PF-06882961
AUClast,u was defined as unbound area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.
Time frame: 0 (pre dose), 4 hours (post dose) on Day 1
Apparent Clearance (CL/F) of Plasma PF-06882961
Apparent Clearance After Oral Dose (CL/F) was defined as apparent clearance after oral dose on the last day of treatment period.
Time frame: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3
Apparent Clearance of Unbound Drug After Oral Administration (CLu/F) of Plasma PF-06882961
CLu/F was defined as apparent clearance of unbound drug.
Time frame: 0 (pre dose), 4 hours (post dose) on Day 1
Apparent Volume of Distribution (Vz/F) of Plasma PF-06882961
Vz/F was defined as apparent volume of distribution.
Time frame: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3
Unbound Vz/F (Vz,u/F) of Plasma PF-06882961
Vz,u/F was defined as apparent volume of distribution of unbound drug.
Time frame: 0 (pre dose), 4 hours (post dose) on Day 1
Time of Observed Maximum Plasma Concentration (Tmax) of Plasma PF-06882961
Tmax was defined as time to maximum observed concentration. Observed directly from data as time of first occurrence.
Time frame: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3
Terminal Elimination Half-Life (T1/2) of Plasma PF-06882961
Plasma terminal elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by one half at the terminal phase.
Time frame: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason.
Time frame: From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Laboratory test abnormalities included hematology, chemistry and urinalysis.
Time frame: From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
Number of Participants With Abnormal Vital Signs
The vital signs were measured included pulse rate (beats/min) and blood pressure (mmHg).
Time frame: From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
Number of Participants With Abnormal Electrocardiograms (ECGs)
ECG parameters included QTCF, PR interval, and QRS interval.
Time frame: From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)