NCT06036108已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of Brexpiprazole in Plasma After Administration in a Fed State Versus Administration in a Fasting State
研究概览
简要总结
To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Fasting-state administration group
Experimental
Brexpiprazole QW formulation in a fasting-state administration
干预措施: OPC-34712FUM/ Brexpiprazole fumarate (Drug)
Fed-state administration group
Experimental
Brexpiprazole QW formulation in a fed-state administration
干预措施: OPC-34712FUM/ Brexpiprazole fumarate (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Brexpiprazole in Plasma After Administration in a Fed State Versus Administration in a Fasting State
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
研究点 (1)
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