Purpose

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 enrolled in group 1 (participants without loss of liver function) and group 3 (participants with moderate loss of liver function). In group 4 (participants with severe loss of function), around 4 to 8 participants will be enrolled. Participants in group 2 (mild loss of function) will only be enrolled after review of the data from groups 3 and 4. 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) at least 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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1
No hepatic impairment
  • Drug: PF-07817883
    Experimental
Experimental
Cohort 2
Mild hepatic impairment
  • Drug: PF-07817883
    Experimental
Experimental
Cohort 3
Moderate hepatic impairment
  • Drug: PF-07817883
    Experimental
Experimental
Cohort 4
Severe hepatic impairment
  • Drug: PF-07817883
    Experimental

Recruiting Locations

More Details

NCT ID
NCT05884554
Status
Completed
Sponsor
Pfizer

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.