Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

Study Overview
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Brief Summary
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To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.

Official Title
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A Multicenter, Randomized, Open-label, 2-arm, 2-period Crossover Trial to Investigate the Effects of Food on the Pharmacokinetics of a Single Dose of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: OPC-34712FUM/ Brexpiprazole fumarate
* Drug: OPC-34712FUM/ Brexpiprazole fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of schizophrenia based on DSM-5® at the time of informed consent Patients who are able to be hospitalized for the protocol-defined hospitalization period Patients with a body mass index [BMI = body weight (kg)/height (m)²] of 18.5 kg/m² or higher and lower than 35.0 kg/m² at screening Patients who, in the judgment of the investigator, have stable psychotic symptoms maintained by administration of an antipsychotic within the dosing range indicated below, before commencement of IMP administration [Upper limit of dose and regimen] Antipsychotic medication comprising no more than 2 active components, and a daily dose equivalent to ≤600 mg/day of chlorpromazine Patients who are able to finish the high-fat meal specified in this protocol within 20 minutes Exclusion Criteria: Patients with a concurrent mental disorder besides schizophrenia who are judged by the investigator to be unsuitable for participation in the trial Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days before commencement of investigational medicinal product (IMP) administration Patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior Patients who answered yes to Question 4 Active Suicidal Ideation with Some Intent to Act, without Specific Plan or Question 5 Active Suicidal Ideation with Specific Plan and Intent regarding C-SSRS suicidal ideation at screening (for the past 6 months) or at the Period 1 baseline examination (since the last assessment) Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at the Period 1 baseline examination (since the last assessment) Patients who present a serious risk of suicide based on the judgment of the investigator Patients who have previously undergone gastrointestinal surgery that could affect PK evaluation Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and PK assessments. Patients who are using clozapine at the time of informed consent Patients whose clinical symptoms have worsened to the point where use of prohibited concomitant therapy or medication is required during the washout period for prior medication Patients whose cytochrome P450 2D6 (CYP2D6) phenotype is judged to be either poor metabolizers (PM) or Unknown based on the results of CYP2D6 genotyping at screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting-state administration group<br>Brexpiprazole QW formulation in a fasting-state administration | Drug: OPC-34712FUM/ Brexpiprazole fumarate<br>* In Period 1, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered at least 10 hours of fasting. In Period 2, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal.<br>|
| Experimental: Fed-state administration group<br>Brexpiprazole QW formulation in a fed-state administration | Drug: OPC-34712FUM/ Brexpiprazole fumarate<br>* In Period 1, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal. In Period 2, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered following at least 10 hours of fasting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state | To evaluate Cmax of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state | PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose | 
| Area Under Curve (AUC) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state | To evaluate AUC of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state | PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose |