Study Detail

« Back to Search Results Notify Me When Search is Updated

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

ClinicalTrials.gov Identifier: NCT05386589 (view full study on clinicaltrials.gov)
Condition:  Hepatic Impairment
Status:  Completed


Official Title: An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482) in Participants with Moderate Hepatic Impairment

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.

Study Type:
Interventional
Study Phase:
Phase 1
Enrollment:
14
Study Start Date:
June 2022
Study Completion Date:
January 2023
Primary Completion Date:
December 2022
Ages Eligible for Study:
18 years to 75 years
Genders Eligible for Study:
All
Accepts Healthy Volunteers:
Yes


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.

No Contacts or Locations in US/Canada Provided

Click here to access ClinicalTrials.gov site to view results.


Clinical Study Reports

Synopsis  MK-4482-016_V01


Find a Study in US or Canada

Advanced Search    Search All Studies

RELATED INFORMATION



Copyright © 2025 · Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved. · This site is intended only for residents of the United States.
Cookie Preferences  Privacy  Terms of Use  Consumer Health Data Privacy Policy  Your Privacy Choices   Accessibility  U.S. Corporate Site

Accessibility icon