Clinical trial NCT06036108: Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state
timeFrame: PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose
measure: Area Under Curve (AUC) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state
timeFrame: PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Saga-shi
country: Japan
facility: Rainbow & Sea Hospital
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Takehisa Matsumaru
role: STUDY_DIRECTOR
References: