JPRN-jRCT2071230059招募中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
Matsumaru Takehisa0 个研究点目标入组 50 人开始时间: 2023年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 65age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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