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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: Completed Phase 1 study of Schizophrenia, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Electrocardiogram data was obtained using a digital Holter device and the Fridericia correction of the QT interval (QTcF) was determined. The change from baseline in QTcF (ΔQTcF \[msec\]) was calculated by subtracting the QTcF value at the timepoint from the QTcF baseline value. Negative values represent a decrease from baseline and vice versa. An average of up to 9 predose ECGs on Day 1 served as baseline to compare postdose effects. Per protocol, the primary endpoint compares MK-8189 to placeb
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2024-02-22 |
| Phase | Phase 1 |
What the finished NCT05893862 record still lists
NCT05893862 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (51% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05893862's enrollment target sits among peer trials
107 131st of 315 higher than 184 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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