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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-14

Study Completion Date

2023-01-05

Brief Summary

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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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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moderate Hepatic Impairment

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

Group Type EXPERIMENTAL

Molnupiravir

Intervention Type DRUG

Four 200 mg capsules administered orally as a single dose

Healthy-Matched Control Group

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

Group Type EXPERIMENTAL

Molnupiravir

Intervention Type DRUG

Four 200 mg capsules administered orally as a single dose

Interventions

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Molnupiravir

Four 200 mg capsules administered orally as a single dose

Intervention Type DRUG

Other Intervention Names

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MK-4482, MOV EIDD-2801

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes