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

• Status: Not yet recruiting
• Trial end date: 2024-01-24
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC
• Treatments: Moxifloxacin

Criteria

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.