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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05386589
Collaborator
(none)
17
Enrollment
3
Locations
2
Arms
5.2
Anticipated Duration (Months)
5.7
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
17 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment
Actual Study Start Date :
Jun 14, 2022
Anticipated Primary Completion Date :
Nov 7, 2022
Anticipated Study Completion Date :
Nov 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Moderate Hepatic Impairment

Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir.

Drug: Molnupiravir
Four 200 mg capsules administered orally as a single dose
Other Names:
  • MK-4482,
  • MOV
  • EIDD-2801

    		•
    Experimental: Healthy-Matched Control Group

    Healthy matched participants will receive a single oral 800mg dose of molnupiravir.

    Drug: Molnupiravir
    Four 200 mg capsules administered orally as a single dose
    Other Names:
  • MK-4482,
  • MOV
  • EIDD-2801

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Plasma N-Hydroxycitidine (NHC) [At designated time points (Up to 72 hours)]

      Blood for plasma samples will be collected at pre-specified time points to determine the AUC0-inf of NHC.

    2. Maximum Plasma Concentration (Cmax) of NHC [At designated time points (Up to 72 hours)]

      Blood for plasma samples will be collected at pre-specified time points to determine the Cmax of NHC.

    Secondary Outcome Measures

    1. Number of participants experiencing Adverse events (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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Centers of America ( Hollywood ) ( Site 0002) Hollywood Florida United States 33024
    2 Clinical Pharmacology of Miami ( Site 0003) Miami Florida United States 33014
    3 Thomas Jefferson University - Pharmacology and Experimental Therapeutics ( Site 0001) Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT05386589
    Other Study ID Numbers:
    • 4482-016
    • MK-4482-016
    First Posted:
    May 23, 2022
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Aug 1, 2022