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.
Drug: PF-07321332
Tablet
Drug: Ritonavir
PK Boosting agent
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).
Orange County Research Center
Tustin, California, United States
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States
Pfizer CT.gov Call Center, Study Director
Pfizer