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Study identifier: NCT05893862 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: CompletedTQT

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)

Condition: Schizophrenia  ·  Sponsor: Merck Sharp & Dohme LLC

PhasePhase 1
Planned participants107
Who can joinAll sexes, 18 Years to 60 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where4 locations

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * 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. Exclusion Criteria: * 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 seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures. * History of cancer. * 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). * 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). * Had major surgery, donated, or lost 1 unit of blood within 4 weeks prior to the pre-study visit.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

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

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