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

• Status: Recruiting
• Trial end date: 2021-12-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Ritonavir

Criteria

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).