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A Double-Blind, Cross-Over Placebo-Controlled and Active-Controlled Trial To Evaluate The Effect Of A Supratherapeutic Dose Of MK-8189 On The QTc Interval In Participants With Schizophrenia
The primary purpose of this study to evaluate the effect of a supratherapeutic dose of 80 mg MK-8189 on the QT interval corrected for heart rate (QTc interval) and to assess the safety and tolerability of multiple once-daily doses of MK-8189 in participants with schizophrenia. The effects of 3 treatment sequences 1) MK-8189 (48 mg \[Day 1\] and 80 mg \[Day2\]); 2) standard image placebo (Day 1) and moxifloxacin 400 mg (Day 2); and 3) MK-8189 placebo (Day 1 and Day 2) were assessed with 5-day washout intervening sequence. Participants received all treatments in a counter-balanced order according to 1 of 6 possible treatment sequences. The primary hypothesis is that the administration of an 80 mg MK-8189 dose on Day 2 does not prolong the QTc interval to a clinically significant degree. Specifically, the true mean difference (MK-8189 - placebo) in QTc change from baseline is less than 10 milliseconds (msec).
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0003)
Glendale, California, United States
NRC Research Institute ( Site 0004)
Orange, California, United States
Velocity Clinical Research, Hallandale Beach ( Site 0002)
Hallandale, Florida, United States
Hassman Research Institute Marlton Site ( Site 0001)
Marlton, New Jersey, United States
Start Date
June 26, 2023
Primary Completion Date
February 22, 2024
Completion Date
February 22, 2024
Last Updated
April 22, 2025
107
ACTUAL participants
MK-8189
DRUG
Moxifloxacin
DRUG
Placebo
DRUG
Lead Sponsor
Merck Sharp & Dohme LLC
NCT07455929
NCT06740383
Data Source & Attribution
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