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drugset / Trial / NCT04676425

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

NCT04676425 ↗

Phase 1 Completed 14 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-03-17
Primary completion
2022-01-16
Completion
2022-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8189 Small molecule 4 mg Oral

Indications

No indication recorded.