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drugset / Trial / NCT02181803

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

NCT02181803 ↗

Phase 1 Completed 55 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8189 Small molecule 2 mg Oral
Subject MK-8189 Small molecule 4 mg Oral
Subject MK-8189 Small molecule 8 mg Oral
Subject MK-8189 Small molecule 10 mg Oral
Subject MK-8189 Small molecule 12 mg Oral
Subject MK-8189 Small molecule 14 mg Oral
Subject MK-8189 Small molecule 16 mg Oral
Subject MK-8189 Small molecule 20 mg Oral
Subject MK-8189 Small molecule 40 mg Oral
Background Aripirprazole Unknown — —
Background Asenapine Other / unclassified — —
Background Iloperidone Small molecule — —
Background Lurasidone Small molecule — —
Background Olanzapine Small molecule — —
Background Paliperidone Unknown — —
Background Quetiapine Small molecule — —
Background Risperidone Other / unclassified — —
Background Ziprasidone Small molecule — —

Indications

schizophrenia