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A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction

CompletedPhase 1

Sponsor: Pfizer

Conditions: Hepatic Impairment, Healthy Volunteers

Interventions: PF-07081532

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (2)

Orlando, Florida, United States
Tampa, Florida, United States