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COMPLETED
NCT05893862
PHASE1

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

View on ClinicalTrials.gov

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

DRUG

Elpipodect

Oral Tablet

DRUG

Moxifloxacin

Oral Tablet

DRUG

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