A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Hepatic Impairment

Treatments

Drug: Molnupiravir

Study type

Interventional

Funder types

Industry

Identifiers

NCT05386589

4482-016

MK-4482-016 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics (PK) of N-hydroxycytidine (NHC) following a single oral dose of molnupiravir in participants 18 to 75 years (inclusive) with moderate hepatic impairment and healthy matched controls.

Enrollment

14 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Has a BMI ≥18.5 and ≤35 kg/m2
Diagnosis of chronic (>6 months) stable Hepatic Impairment (HI) with features of cirrhosis due to any etiology (Moderate HI arm only)
Has a score on the Child-Pugh scale ranging from 7 to 9 (Moderate HI arm only)
In good health (except for Moderate HI)

Exclusion Criteria:

Anticipated survival of <3 months (Moderate HI arm only)
Received antiviral and/or immune modulating therapy (Moderate HI only) for Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) within 90 days prior to study start
History of clinically significant abnormalities or diseases (Healthy matched arm only).
History of cancer
Major surgery and/or donated or lost 1 unit of blood
Taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month (Moderate HI arm only) and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 8 hours after administration of the study drug.