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COMPLETED
NCT04676425
PHASE1

A Study to Investigate the Influence of Hepatic Impairment on Elpipodect (MK-8189) Treatment (MK-8189-012)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

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