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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: OPC-34712FUM/ Brexpiprazole fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06036108

331-102-00151

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Fasting-state administration group

Experimental group

Description:

Brexpiprazole QW formulation in a fasting-state administration

Treatment:

Drug: OPC-34712FUM/ Brexpiprazole fumarate

Drug: OPC-34712FUM/ Brexpiprazole fumarate

Fed-state administration group

Experimental group

Description:

Brexpiprazole QW formulation in a fed-state administration

Treatment:

Drug: OPC-34712FUM/ Brexpiprazole fumarate

Drug: OPC-34712FUM/ Brexpiprazole fumarate