A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.

Study Overview
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Brief Summary
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The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups. This study is seeking participants who: are male or female of 18- 75 years of age either have different amounts of damage to liver function or for one of the groups, no damage willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days About, 6-8 participants will be selected in groups 1, 2 and 3. In group 4, around 4 to 8 participants will be selected. If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) atleast 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.

Official Title
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A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO ASSESS PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

Conditions
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COVID-19

Intervention / Treatment
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* Drug: PF-07817883


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (HI Cohorts Only): Stable HI that meets criteria for Class A or B of the Child-Pugh classification; (all Cohorts): BMI of 17.5 to 38.0 kg/m2 Exclusion Criteria: Any condition possibly affecting drug absorption Additional Exclusion Criteria for HI Cohorts Only Limited predicted life expectancy Hepatic dysfunction secondary to acute ongoing hepatocellular process. Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy. Severe ascites and/or pleural effusion History of kidney, liver, or heart transplantation. Persistent severe, uncontrolled hypertension.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>No hepatic impairment | Drug: PF-07817883<br>* Experimental<br>|
| Experimental: Cohort 2<br>Mild hepatic impairment | Drug: PF-07817883<br>* Experimental<br>|
| Experimental: Cohort 3<br>Moderate hepatic impairment | Drug: PF-07817883<br>* Experimental<br>|
| Experimental: Cohort 4<br>Severe hepatic impairment | Drug: PF-07817883<br>* Experimental<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of PF-07817883 | Plasma PF-07817883 PK parameters | Day 1 to Day 6 | 
| Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf) | Plasma PF-07817883 PK parameter | Day 1 to Day 6 | 
| Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) | (Optional) Plasma PF-07817883 parameter | Day 1 to Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Non-Serious Adverse Events | Safety Parameters | Screening to Day 35 | 
| Number of Participants with Treatment Emergent Adverse Events | Safety Parameters | Day 1 to Day 35 | 
| Number of Participants with Clinically Significant ECG Abnormalities | ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate | Day 1 to Day 6 | 
| Number of Participants with Clinically Significant Abnormal Vital Signs | Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate | Day 1 to Day 6 | 
| Number of Participants with Clinically Significant Abnormal Laboratory Values | Blood hematology and Chemistry and Urinalysis | Baseline to Day 6 | 
| Number of Participants with Serious Adverse Events | Safety Parameters | Screening to Day 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Impairment, COVID-19