The purpose of this study is to understand the effects of liver functional impairment on the study medicine (PF-07081532). People with liver functional impairment may process the study medicine differently from healthy people. We are seeking participants who: * Are between 18 and 70 years of age; * Have a BMI (body mass index) of 17.5 to 38.0 kg/m2, inclusive, and a total body weight \>50 kg (110 lbs.). Participants will take the study medicine as a tablet once at the study clinic, and then will stay onsite for about 7 days. During this time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain level of liver functional impairment could affect the study medicine being processed in the body.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1
Orlando Clinical Research Center
Orlando, Florida, United States
Genesis Clinical Research, LLC
Tampa, Florida, United States
Maximum Plasma Concentration (Cmax) of PF-07081532
Cmax is the maximum plasma concentration.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07081532
AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532
AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
Fraction of Unbound Drug in Plasma (Fu) of PF-07081532
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, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
Unbound Cmax (Cmax,u) of PF-07081532
Cmax,u is the unbound Cmax.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
Unbound AUCinf (AUCinf,u) of PF-07081532
AUCinf,u is the unbound AUCinf.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
Unbound AUClast (AUClast,u) of PF-07081532
AUClast,u is the unbound AUClast.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were defined as events that started during the effective duration of treatment (ie, starting on or after the dose of PF-07081532 up to the final follow-up visit). AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Time frame: Day 1 to Day 36
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Safety laboratory assessments included clinical chemistry, hematology, and urinalysis tests. Number of participants with clinical laboratory abnormalities meeting pre-specified criteria is reported.
Time frame: From baseline (BL) to Day 7
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Vital signs abnormalities included: seated diastolic blood pressure (BP) increase and decrease from BL of \>=20mmHg or absolute value \<50mmHg; systolic BP increase and decrease from BL of \>=30mmHg or absolute value \<90mmHg; pulse rate \<40 or \>120bpm.
Time frame: From BL to Day 7
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
ECG assessments included PR interval, QT interval, QTcF, and QRS complex. ECG abnormalities included PR interval BL \>200msec and max ≥25% increase from BL, or BL ≤200msec and max ≥50% increase from BL, or absolute value ≥300msec; QRS interval percent change from BL ≥50% or absolute value ≥140msec; QTcF change from BL 30- ≤60msec, \>60msec, or absolute value 450- ≤480msec, 480- ≤500msec, or \>500msec.
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Time frame: From BL to Day 7