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A Study To Evaluate The Effect Of A Supratherapeutic Dose Of Elpipodect (MK-8189) On The QTc Interval In Participants With Schizophrenia (MK-8189-019)
Sponsor: Merck Sharp & Dohme LLC
Summary
The primary purpose of this study to evaluate the effect of a supratherapeutic dose of 80 mg elpipodect on the QT interval corrected for heart rate (QTc interval) and to assess the safety and tolerability of multiple once-daily doses of elpipodect in participants with schizophrenia. The effects of 3 treatment sequences 1) elpipodect (48 mg \[Day 1\] and 80 mg \[Day2\]); 2) standard image placebo (Day 1) and moxifloxacin 400 mg (Day 2); and 3) elpipodect 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 elpipodect dose on Day 2 does not prolong the QTc interval to a clinically significant degree. Specifically, the true mean difference (elpipodect - placebo) in QTc change from baseline is less than 10 milliseconds (msec).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
107
Start Date
2023-06-26
Completion Date
2024-02-22
Last Updated
2026-04-29
Healthy Volunteers
No
Conditions
Interventions
Elpipodect
Oral Tablet
Moxifloxacin
Oral Tablet
Placebo
Oral Tablet
Locations (4)
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