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

CompletedPhase 1

Sponsor: Pfizer

Conditions: Hepatic Impairment

Interventions: PF-07321332, Ritonavir

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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).

Locations (2)

Tustin, California, United States
Saint Paul, Minnesota, United States