Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332

Purpose

The study is to estimate the effect of hepatic impairment on the plasma PK of PF-07321332/ritonavir. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of hepatic impairment.

Condition

  • Hepatic Impairment

Eligibility

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

Inclusion Criteria

  • Male and female participants who are classically healthy having no clinically relevant abnormalities. No known or suspected hepatic impairment - Stable hepatic impairment that meets the criteria for Class B of the Child-Pugh Classification

Exclusion Criteria

  • Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection). - Participants who have been vaccinated with COVID-19 vaccines within the past week of dosing - A positive urine drug test, for illicit drugs, at Screening - History of sensitivity reactions to ritonavir or any of the formulation components of PF-07321332 or ritonavir. - eGFR <60 mL/min/1.73m2 based on the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥ upper limit of normal (ULN) (for healthy participants); AST or ALT > 5x ULN (for hepatic impairment participants) - Albumin > ULN (for healthy participants); - Prothrombin time > ULN (for healthy participants); - Total bilirubin level ≥1.5 × ULN [NOTE: Participants with a history of Gilbert syndrome (and hence elevated total bilirubin) are eligible provided direct bilirubin level is ≤ ULN).

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 		Healthy Volunteer
  • Drug: PF-07321332
    Tablet
  • Drug: Ritonavir
    PK Boosting agent
Experimental
Cohort 2 		Hepatic Impairment
  • Drug: PF-07321332
    Tablet
  • Drug: Ritonavir
    PK Boosting agent

Recruiting Locations

More Details

NCT ID
NCT05005312
Status
Completed
Sponsor
Pfizer