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A Study to Investigate the Influence of Hepatic Impairment on Elpipodect (MK-8189) Treatment (MK-8189-012)
Sponsor: Merck Sharp & Dohme LLC
Summary
The purpose of this study is to compare the pharmacokinetics (PK) of elpipodect in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants. This is Part 1 of the study; following review of the safety and PK data from Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done, Part 2 of the study will compare the PK of elpipodect in participants with mild hepatic impairment to healthy participants.
Official title: A 2-part, Open-label, Single-dose Study to Investigate the Influence of Hepatic Impairment on the Pharmacokinetics of MK-8189
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2021-03-17
Completion Date
2022-01-25
Last Updated
2026-04-29
Healthy Volunteers
Yes
Conditions
Interventions
Elpipodect
Administered at a dose of 4 mg via oral tablet
Locations (2)
ProSciento Inc. ( Site 0002)
Chula Vista, California, United States
Clinical Pharmacology of Miami ( Site 0001)
Miami, Florida, United States