A food effects trial of the pharmacokinetics of brexpiprazole once-weekly (QW) formulation in patients with schizophrenia

JRCT ID: jRCT2071230059

Registered date:06/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: schizophrenia
• Date of first enrollment: 03/10/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): To investigate the effect of food on the pharmacokinetics (PK) of a single dose of brexpiprazole QW formulation at 48 mg in patients with schizophrenia.

Outcome(s)

• Primary Outcome: Cmax, AUCinfinity, and AUCt of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1)Patients with a diagnosis of schizophrenia based on DSM-5 at the time of informed consent
2)Patients who are able to be hospitalized for the protocol-defined hospitalization period
3)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
4)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
5)Patients who are able to finish the high-fat meal specified in this protocol within 20 minutes

Exclude criteria

1) Patients with a concurrent mental disorder besides schizophrenia who are judged by the investigator to be unsuitable for participation in the trial
2) Patients who have met the DSM-5R 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
3) 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
4) Patients who have previously undergone gastrointestinal surgery that could affect PK evaluation
5) 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.
6) Patients who are using clozapine at the time of informed consent
7) 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
8) 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

Related Information

• Primary Sponsor: Tsunoda Takeshi