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

• Status: Not yet recruiting
• Trial end date: 2022-11-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme LLC

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.