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

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05386589
• Other study ID #: 4482-016
• Secondary ID: MK-4482-016
• Status: Completed
• Phase: Phase 1
• Start date: June 14, 2022
• Est. completion date: January 5, 2023

Study information

• Verified date: November 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 5, 2023
• Est. primary completion date: December 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Molnupiravir
Four 200 mg capsules administered orally as a single dose

Locations

Country	Name	City	State
United States	Research Centers of America ( Hollywood ) ( Site 0002)	Hollywood	Florida
United States	Clinical Pharmacology of Miami ( Site 0003)	Miami	Florida
United States	Thomas Jefferson University - Pharmacology and Experimental Therapeutics ( Site 0001)	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-8) of Plasma N-Hydroxycitidine (NHC)	The plasma AUC0-8 of NHC is reported.	Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose
Primary	Maximum Plasma Concentration (Cmax) of NHC	The plasma Cmax of NHC is reported.	Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose
Secondary	Number of Participants Experiencing =1 Adverse Event (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

External Links

•   Merck Clinical Trials Information