NCT01892384已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 409306 Film-coated Tablets Given Orally q.d. for 14 Days in Patients With Schizophrenia (Randomized, Parallel-group, Double-blind, Placebo-controlled Study)
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
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Drug-related Adverse Events
研究概览
简要总结
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in schizophrenic patients following oral administration of multiple low, medium, and high doses over 14 days.
A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 409306 in schizophrenic patients.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 409306 dose 1
Experimental
low dose, once daily
干预措施: BI 409306 (Drug)
BI 409306 dose 2
Experimental
medium dose, once daily
干预措施: BI 409306 (Drug)
BI 409306 dose 3
Experimental
high dose, once daily
干预措施: BI 409306 (Drug)
Placebo
Placebo Comparator
placebo, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Drug-related Adverse Events
时间窗: From first drug administration until 30 days after last drug administration, up to 44 days.
Number of participants with drug-related adverse events.
次要结局
- Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After a Single Dose (AUC0-infinity)(2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration.)
- Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Cmax)(2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration)
- Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Cmax,ss)(2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.)
- Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Tmax)(2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration.)
- Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Tmax,ss)(2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.)
- Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss)(2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.)
研究者
研究点 (1)
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