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

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Molnupiravir

About this trial

This is an interventional treatment trial for Hepatic Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Research Centers of America ( Hollywood ) ( Site 0002)
Clinical Pharmacology of Miami ( Site 0003)
Thomas Jefferson University - Pharmacology and Experimental Therapeutics ( Site 0001)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Moderate Hepatic Impairment

Healthy-Matched Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Maximum Plasma Concentration (Cmax) of NHC

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

Secondary Outcome Measures

Number of participants experiencing Adverse events (AE)

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.

Full Information

NCT ID

NCT05386589

First Posted

May 18, 2022

Last Updated

January 24, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT05386589

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

June 14, 2022 (Actual)

Primary Completion Date

December 18, 2022 (Actual)

Study Completion Date

January 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moderate Hepatic Impairment

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy-Matched Control Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Molnupiravir

Other Intervention Name(s)

MK-4482,, MOV, EIDD-2801

Intervention Description

Four 200 mg capsules administered orally as a single dose

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

At designated time points (Up to 72 hours)

Title

Maximum Plasma Concentration (Cmax) of NHC

Description

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

Time Frame

At designated time points (Up to 72 hours)

Secondary Outcome Measure Information:

Title

Number of participants experiencing Adverse events (AE)

Description

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.

Time Frame

Up to ~ 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Research Centers of America ( Hollywood ) ( Site 0002)

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Clinical Pharmacology of Miami ( Site 0003)

City

Miami

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

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

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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

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