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

Study Overview
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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.

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

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: Molnupiravir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Hepatic Impairment<br>Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir. | Drug: Molnupiravir<br>* Four 200 mg capsules administered orally as a single dose<br>* Other names: EIDD-2801;|
| Experimental: Healthy-Matched Control Group<br>Healthy matched participants will receive a single oral 800mg dose of molnupiravir. | Drug: Molnupiravir<br>* Four 200 mg capsules administered orally as a single dose<br>* Other names: EIDD-2801;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At designated time points (Up to 72 hours) | 
| Maximum Plasma Concentration (Cmax) of NHC | Blood for plasma samples will be collected at pre-specified time points to determine the Cmax of NHC. | At designated time points (Up to 72 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to   14 days |