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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
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
Oral tablets of dose-matched placebo to MK-8189 according to randomization
Woodland Research Northwest, LLC ( Site 0002)
Rogers, Arkansas, United States
Parexel ( Site 0004)
Glendale, California, United States
Collaborative NeuroScience Network ( Site 0008)
Long Beach, California, United States
Velocity Clinical Research, Hallandale Beach ( Site 0001)
Hallandale, Florida, United States
Part 1 & 2: Number of Participants Who Experienced an Adverse Event (AE)
The number of participants with ≥1 AE is reported. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 27 days
Part 1 & 2: Number of Participants Discontinuing Study Treatment Due to an AE
The number of participants discontinuing from study treatment due to ≥1 AE is reported. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 27 days
Part 1: Area Under the Concentration Time-curve From Hour 0 to 24 Hours Postdose (AUC0-24) of MK-8189
AUC0-24 was determined for participants in Part 1 panels who received MK-8189.
Time frame: Days 1, 2, 4, and Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 1: Concentration 24 Hours Postdose (C24) of MK-8189
C24 was determined for participants in Part 1 panels who received MK-8189.
Time frame: Days 1, 2, 4, and Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 1: Maximum Plasma Concentration (Cmax) of MK-8189
Cmax was determined for participants in Part 1 panels who received MK-8189.
Time frame: Days 1, 2, 3, 4, and Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 1: Time to Maximum Concentration (Tmax) of MK-8189
Tmax was determined for participants in Part 1 panels who received MK-8189.
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RCA at Fort Lauderdale Behavioral Health Center ( Site 0006)
Oakland Park, Florida, United States
Hassman Research Institute ( Site 0007)
Berlin, New Jersey, United States
Time frame: Days 1, 2, 3, 4, and Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 1: Clearance (CL/F) of MK-8189
CL/F was determined for participants in Part 1 panels who received MK-8189.
Time frame: Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 1: Apparent Terminal Half-life (t½) of MK-8189
t½ was determined for participants in Part 1 panels who received MK-8189.
Time frame: Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 1: Volume of Distribution (Vd/F) of MK-8189
Vd/F was determined for participants in Part 1 panels who received MK-8189.
Time frame: Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: AUC0-24 of MK-8189
AUC0-24 was determined for participants in Part 2 panels who received MK-8189.
Time frame: Days 1, 4, 7, 10, and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: C24 of MK-8189
C24 was determined for participants in Part 2 panels who received MK-8189.
Time frame: Days 1, 4, 7, 10, and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Cmax of MK-8189
Cmax was determined for participants in Part 2 panels who received MK-8189.
Time frame: Days 1, 4, 7, 10, and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Tmax of MK-8189
Tmax was determined for participants in Part 2 panels who received MK-8189.
Time frame: Days 1, 4, 7, 10, and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: CL/F of MK-8189
CL/F was determined for participants in Part 2 panels who received MK-8189.
Time frame: Days 10 and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: t½ of MK-8189
t½ was determined for participants in Part 2 panels who received MK-8189.
Time frame: Days 10 and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Vd/F of MK-8189
Vd/F was determined for participants in Part 2 panels who received MK-8189.
Time frame: Days 10 and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose