CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 63 enrolled
Drug / intervention
Elpipodect +1 moredrug
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/NCT04506905
NCT04506905Phase 1Completed
CompareCT.gov

A 2-Part Randomized Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Alternate MK-8189 Titration Regimens in Young Adult Participants With Schizophrenia and to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8189 in Elderly Participants With Schizophrenia and Healthy Elderly

Merck Sharp & Dohme LLC·interventional·Posted Aug 10, 2020·Updated Apr 29, 2026

In Brief

A Phase 1 clinical trial evaluating Elpipodect and Placebo for Schizophrenia. Completed, enrolled 63 participants across 6 sites.

Detailed Summary

This is a randomized, double-blind, 2-part clinical study of the safety, tolerability and pharmacokinetics of alternate elpipodect titration regimens. Part 1 assessed multiple dose once-daily titration regimens of elpipodect in young adult participants with schizophrenia. Part 2 assessed multiple once-daily doses of elpipodect in elderly participants with schizophrenia and healthy elderly participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedAug 10, 2020
Enrollment StartAug 28, 2020
Primary CompletionMar 22, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.9 years ago

Interventions

Elpipodectdrug

MK-8189, oral, 4 mg and/or 12 mg tablets for a total daily dose of 8, 16 or 24 mg QD according to randomization

Placebodrug

Oral tablets of dose-matched placebo to MK-8189 according to randomization