At a glance
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A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8189 in Healthy Volunteers and in Schizophrenia Patients
In Brief
A Phase 1 clinical trial evaluating Elpipodect, Placebo, and 1 other intervention for Schizophrenia. Completed, enrolled 55 participants.
Detailed 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.
Study Details
Timeline
Interventions
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
Placebo matching oral 2 mg and/or 10 mg MK-8189 tablets, taken QD
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.