NCT05893862CompletedPhase 1
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)
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
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 107 (actual)
- First submitted
- 30 May 2023
- Start date
- 26 Jun 2023
- Primary completion date
- 22 Feb 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Schizophrenia
- NCT number
- NCT05893862
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 107
- From 26 Jun 2023 to the primary completion date, 22 Feb 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
- Had major surgery, donated, or lost 1 unit of blood within 4 weeks prior to the pre-study visit.
Other illness
- History of a primary DSM-5 axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder per the allowed DSM-5 criteria.
- History of intellectual disability, borderline personality disorder, anxiety disorder, or organic brain syndrome.
- History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia (TD).
- History of cancer.
- History of frequent syncope, vasovagal episodes, or epileptic seizures.
- Family history of sudden cardiac death.
- Has a positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Lab values
- History or presence of sick sinus syndrome, atrioventricular (AV) block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QTc interval, or conduction abnormalities.
- History of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome).
Who the study is looking for
- Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
- Is in the non-acute phase of their illness.
- Has a history of receiving and tolerating antipsychotics medication within the usual dose range employed for schizophrenia.
- Participants with hypothyroidism, diabetes, high blood pressure, chronic respiratory conditions or other medical conditions could be considered if their condition is stable.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0003) Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Velocity Clinical Research, Hallandale Beach ( Site 0002) Coordinator of this site? Confirm its status | Hallandale | United States | Unknown status |
| Hassman Research Institute Marlton Site ( Site 0001) Coordinator of this site? Confirm its status | Marlton | United States | Unknown status |
| NRC Research Institute ( Site 0004) Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.