Status:
COMPLETED
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 hepa...
Eligibility Criteria
Inclusion
- The key inclusion and exclusion criteria include but are not limited to the following:
- 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
- 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.
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05386589
Start Date
June 14 2022
End Date
January 5 2023
Last Update
January 28 2025
Active Locations (3)
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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