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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2021-12-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1

Healthy Volunteer

Group Type EXPERIMENTAL

PF-07321332

Intervention Type DRUG

Tablet

Ritonavir

Intervention Type DRUG

PK Boosting agent

Cohort 2

Hepatic Impairment

Group Type EXPERIMENTAL

PF-07321332

Intervention Type DRUG

Tablet

Ritonavir

Intervention Type DRUG

PK Boosting agent

Interventions

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PF-07321332

Tablet

Intervention Type DRUG

Ritonavir

PK Boosting agent

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes