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.
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Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189 in Schizophrenia Participants
Timeframe: Day 1, 4, 8, 11 and 14 pre-dose and 24 hours post-dose
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC[0-24hr]) of MK-8189 in Schizophrenia Participants
Timeframe: Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189 in Schizophrenia Participants
Timeframe: Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose
Time Post-dose at Which the Maximum Plasma Concentration (Tmax) of MK-8189 Was Observed in Schizophrenia Participants
Timeframe: Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose
Time Required for Plasma Concentration of MK-8189 to Decrease by Half (Apparent t1/2) in Schizophrenia Participants on Day 14
Timeframe: Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose
Number of Participants Experiencing an Adverse Event (AE)
Timeframe: Up to Day 28
Number of Participants Who Discontinue From Study Treatment Due to an AE
Timeframe: Up to Day 14