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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: OPC-34712FUM/ Brexpiprazole fumarate

• Registration Number: NCT06036108
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-13
• Study Start: 2023-10-03
• Primary Completion: 2025-03-18
• Status Verified: 2025-04
• Study Completion: 2025-04-08
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fasting-state administration group	OPC-34712FUM/ Brexpiprazole fumarate	Brexpiprazole QW formulation in a fasting-state administration
Fed-state administration group	OPC-34712FUM/ Brexpiprazole fumarate	Brexpiprazole QW formulation in a fed-state administration

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of brexpiprazole in plasma after administration 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	To evaluate Cmax of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state
Area Under Curve (AUC) of brexpiprazole in plasma after administration 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	To evaluate AUC of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state

Trial Locations

Locations (1)

Rainbow & Sea Hospital; 🇯🇵 Saga-shi, Japan