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Completed

NCT Number: NCT05386589

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 hepatic impairment and healthy matched controls.

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Key information

Conditions

Hepatic Impairment

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Molnupiravir

Drug

Four 200 mg capsules administered orally as a single dose

Other names: MK-4482,, MOV, EIDD-2801

Primary outcomes

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

    Time frame: 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.

  2. Maximum Plasma Concentration (Cmax) of NHC

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 23, 2022
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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