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NCT05893862 · ClinicalTrials.gov registry record · Phase 1

A Study To Evaluate The Effect Of A Supratherapeutic Dose Of MK-8189 On The QTc Interval In Participants With Schizophrenia (MK-8189-019)

A Phase 1 study of Schizophrenia, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 1
Development phase
107
Enrollment target
4
Study locations

NCT05893862 is a Phase 1 study of Schizophrenia that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 107 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (51% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT05893862, a Phase 1 study of Schizophrenia, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 1
Development phase
107 participants
Enrollment target
4
Study locations

Study Summary

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).

Conditions Studied

Schizophrenia

Interventions

  • DRUG Placebo
  • DRUG Moxifloxacin
  • DRUG MK-8189

Study Locations (4)

California

  • California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0003) - Glendale
  • NRC Research Institute ( Site 0004) - Orange

Florida

  • Velocity Clinical Research, Hallandale Beach ( Site 0002) - Hallandale

New Jersey

  • Hassman Research Institute Marlton Site ( Site 0001) - Marlton

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2023-06-26
Est. Completion 2024-02-22
Phase Phase 1

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05893862

The ClinicalTrials.gov registry entry for NCT05893862 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (51% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT05893862 reports 4 study locations spanning 3 distinct geographic areas - top geographies include California, Florida, New Jersey.

Frequently Asked Questions

What is clinical trial NCT05893862 about?

NCT05893862 is a clinical study titled "A Study To Evaluate The Effect Of A Supratherapeutic Dose Of MK-8189 On The QTc Interval In Participants With Schizophrenia (MK-8189-019)". 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 treat...

What is the current status of trial NCT05893862?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2023-06-26. Estimated completion is 2024-02-22.

What conditions does trial NCT05893862 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT05893862?

The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), MK-8189 (DRUG).

Who is sponsoring clinical trial NCT05893862?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05893862 being conducted?

This trial has 4 study locations across California, Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.