a study to understand how the study medicine (pf-07081532) is processed in people with liver dysfunction

Conditions: Hepatic Impairment; Healthy Volunteers

Summary: 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.


Eligibility criteria:
inclusion criteria: * male or female between the ages of 18 and 70 years, inclusive at the screening visit. * willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * bmi of 17.5 to 38.0 kg/m2, inclusive, and a total body weight \>50 kg (110 lb). * 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: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests. * groups 2, 3 \& 4 only: stable hepatic impairment that meets criteria for class a, b, or c of the child-pugh classification with no clinically significant change in disease status within 28 days before screening. * groups 2, 3 \& 4 only: stable concomitant medications for the management of individual participant's medical history. exclusion criteria: * any condition possibly affecting drug absorption * at screening, a positive result for hiv antibodies. * personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2), or participants with suspected mtc per study doctor's judgement. * history of acute pancreatitis within 6 months before the screening visit or any history of chronic pancreatitis. * other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study. * use of specific prohibited prior/concomitant therapies * use of an investigational product within 30 days (or local requirement) or 5 half-lives (whichever longer). * egfr\<60 ml/min/1.73m2 at screening. * a positive urine drug test at screening or admission to study clinic. * at screening or admission to study clinic, a positive breath alcohol test. * for females, pregnancy, as indicated by a positive serum pregnancy test at screening and/or positive urine pregnancy test in women capable of having children at admission to study clinic * group 1 only: evidence of chronic liver disease including history of hepatitis, hepatitis b, or hepatitis c. * group 1 only: history of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening. * 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 1 only: use of chronic prescription medications within 7 days or 5 half-lives (whichever longer) before day 1, or for prohibited medications, use within the required washout/restriction period. * group 2, 3 \& 4 only: hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as \<1 year in groups 2 \& 3 and \<6 months for group 4 only). * group 2, 3 \& 4 only: a diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical exam, liver biopsy, hepatic ultrasound, ct scan, or mri. * group 2, 3 \& 4 only: history of surgery that would be expected to alter absorption, distribution, metabolism, or excretion properties of pf-07081532. * group 2, 3 \& 4 only: history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening. * group 2, 3 \& 4 only: signs of clinically active grade 3 or 4 hepatic encephalopathy * groups 2, 3 \& 4 only: severe ascites and/or pleural effusion, except for those categorized in group 4 who may be enrolled provided participant is medically stable, per the study doctor's judgment. * groups 2, 3 \& 4 only: previously received a kidney, liver, or heart transplant. * groups 2, 3, \& 4 only: screening ecg demonstrating a qtcf interval \>470 ms or a qrs interval \>120 ms. * groups 2, 3 \& 4 only: at screening, admission to study clinic or pre-dose on day 1, persistent severe, uncontrolled hypertension. * groups 2, 3 \& 4 only: alt or ast \>5x upper limit of normal on clinical laboratory tests at screening.

Keywords: hepatic impairment healthy volunteers