CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Elpipodectdrug
Likely dose
Elpipodect 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04676425
NCT04676425Phase 1Completed
CompareCT.gov

A 2-part, Open-label, Single-dose Study to Investigate the Influence of Hepatic Impairment on the Pharmacokinetics of MK-8189

Merck Sharp & Dohme LLC·interventional·Posted Dec 21, 2020·Updated Apr 29, 2026

In Brief

A Phase 1 clinical trial evaluating Elpipodect for Hepatic Impairment. Completed, enrolled 14 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedDec 21, 2020
Enrollment StartMar 17, 2021
Primary CompletionJan 16, 2022
Study CompletionJan 25, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.5 years ago

Interventions

Elpipodectdrug

Administered at a dose of 4 mg via oral tablet