Official Title
A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07321332 BOOSTED WITH RITONAVIR IN ADULT PARTICIPANTS WITH MODERATE HEPATIC IMPAIRMENT AND HEALTHY PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
Brief 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.

Completed
Hepatic Impairment

Drug: PF-07321332

Tablet

Drug: Ritonavir

PK Boosting agent

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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
United States
Locations

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

NCT Number
Keywords
Covid-19
SARS-CoV-2
MeSH Terms
Liver Diseases
Ritonavir
Nirmatrelvir