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Elpipodect (MK-8189) Multiple Dose Study in Healthy Volunteers and Schizophrenia Participants (MK-8189-003)

NCT02181803 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-04-29

Study results available
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Summary

This 3-part dose titration study will assess elpipodect safety, tolerability, pharmacokinetics (PK), and central nervous system activity. Part 1 (Panels A and B) will assess elpipodect administered as monotherapy in participants with schizophrenia. Part 2 (Panel C) will assess elpipodect administered as add-on to atypical antipsychotic treatment in participants with schizophrenia. Part 3 (Panel D) will assess monotherapy with elpipodect in healthy participants, including those of Japanese descent. The primary hypothesis is that there is at least one dose of elpipodect that is generally safe and well-tolerated which will have the desired PK parameters in participants with schizophrenia.

Conditions

Interventions

DRUG

Elpipodect

MK-8189, oral, 2 mg and/or 10 mg tablets, taken QD for a total daily dose of 2 mg, 4 mg, 8 mg, 10 mg, 12 mg, 14 mg, 16 mg, 20 mg, or 40 mg

DRUG

Placebo

Placebo matching oral 2 mg and/or 10 mg MK-8189 tablets, taken QD

DRUG

Base Monotherapy

For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone, Aripirprazole, Lurasidone, Risperidone \[not to exceed daily dose of 6 mg\], or Ziprasidone.) The participant should be on a stable and well tolerated treatment regimen for at least 2 months prior to screening. NOTE: Clozapine is not allowed.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-05
Primary Completion
2015-04-23
Completion
2015-04-23

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02181803 on ClinicalTrials.gov