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

NCT05386589 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 4482-016MK-4482-016
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC)

  The plasma AUC0-∞ of NHC is reported.

  Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose

• Maximum Plasma Concentration (Cmax) of NHC

  The plasma Cmax of NHC is reported.

  Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose

Secondary Outcomes (1)

• Number of Participants Experiencing ≥1 Adverse Event (AE)

  Up to ~ 14 days

Study Arms (2)

Moderate Hepatic Impairment

EXPERIMENTAL

Participants with moderate hepatic impairment received a single oral dose of molnupiravir 800 mg on Day 1.

Drug: Molnupiravir

Healthy-Matched Control Group

EXPERIMENTAL

Healthy matched participants received a single oral dose of molnupiravir 800 mg on Day 1.

Drug: Molnupiravir

Interventions

Molnupiravir DRUG

Four 200 mg capsules administered orally as a single dose

Also known as: MK-4482,, MOV, EIDD-2801

Healthy-Matched Control Group; Moderate Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (3)

Research Centers of America ( Hollywood ) ( Site 0002)

Hollywood, Florida, 33024, United States

Location

Clinical Pharmacology of Miami ( Site 0003)

Miami, Florida, 33014, United States

Location

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

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Duncan KE, Carstens RP, Butterfield KL, Jin Y, Inbody LR, Schaeffer AK, Matthews CZ, Zhao T, Patel S, Maas BM, Cheng MH, Stoch SA. Assessment of pharmacokinetics and tolerability following single-dose administration of molnupiravir in participants with hepatic or renal impairment. Clin Transl Sci. 2024 Dec;17(12):e70073. doi: 10.1111/cts.70073.

  PMID: 39601078 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

molnupiravir

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: June 14, 2022
• Primary Completion: December 18, 2022
• Study Completion: January 5, 2023
• Last Updated: January 28, 2025
• Results First Posted: May 9, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)