A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia (12 Weeks Treatment Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the patient before the initiation of any study-specific procedures
- •Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
- •Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)
排除标准
- •Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
- •The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
MP-214 9mg
干预措施: MP-214 9mg (Drug)
MP-214 3mg
干预措施: MP-214 3mg (Drug)
MP-214 6mg
干预措施: MP-214 6mg (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to 24 weeks
Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
时间窗: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
时间窗: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
时间窗: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
次要结局
未报告次要终点