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COMPLETEDPhase 1NCT05386589

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

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 hepa...

Lead sponsor: Merck Sharp & Dohme LLC•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Merck Sharp & Dohme LLC

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 28, 2025Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment14

Start dateJun 2022

Last updatedJan 28, 2025

Condition

Hepatic Impairment

Locations shown

Research Centers of America ( Hollywood ) ( Site 0002)

Hollywood, Florida

Clinical Pharmacology of Miami ( Site 0003)

Miami, Florida

Thomas Jefferson University - Pharmacology and Experimental Therapeutics ( Site 0001)

Philadelphia, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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