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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Ritonavir; Drug: PF-07321332

Study type: Interventional

Funder types: Industry

Identifiers

NCT05005312

C4671010

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Healthy Volunteer

Treatment:

Drug: Ritonavir

Drug: PF-07321332

Cohort 2

Experimental group

Description:

Hepatic Impairment

Treatment:

Drug: Ritonavir

Drug: PF-07321332