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

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: Molnupiravir

• Registration Number: NCT05386589
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-23
• Study Start: 2022-06-14
• Primary Completion: 2022-12-18
• Study Completion: 2023-01-05
• Results First Submitted: 2023-12-01
• Results First Submitted QC: 2023-12-01
• Results First Posted: 2024-05-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy-Matched Control Group	Molnupiravir	Healthy matched participants received a single oral dose of molnupiravir 800 mg on Day 1.
Moderate Hepatic Impairment	Molnupiravir	Participants with moderate hepatic impairment received a single oral dose of molnupiravir 800 mg on Day 1.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC)	Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose	The plasma AUC0-∞ of NHC is reported.
Maximum Plasma Concentration (Cmax) of NHC	Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose	The plasma Cmax of NHC is reported.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing ≥1 Adverse Event (AE)	Up to ~ 14 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Trial Locations

Locations (3)

Research Centers of America ( Hollywood ) ( Site 0002); 🇺🇸 Hollywood, Florida, United States

Clinical Pharmacology of Miami ( Site 0003); 🇺🇸 Miami, Florida, United States

Thomas Jefferson University - Pharmacology and Experimental Therapeutics ( Site 0001); 🇺🇸 Philadelphia, Pennsylvania, United States