NCT02202226已完成1 期
Interventional, Randomised, Double-blind, Placebo-controlled, Sequential Group, Multiple Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF35700 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
- 96
- 试验地点
- 1
- 主要终点
- Change from baseline in AIMS, BARS and SAS Total score
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women between 18 and 60 years (extremes included)
- •BMI of ≤38
- •Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
- •Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at screening and baseline
- •PANSS total score ≤80
- •Score ≤4 (moderate) on the following PANSS items at screening and safety baseline: P7 (hostility), G8 (uncooperativeness)
- •Willing to be hospitalised for 4 to 5 weeks after the Safety Baseline Visit
排除标准
- •The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
- •The patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks
- •The patient has a diagnosis or history of substance dependence (except nicotine) or substance abuse according to DSM-IV-TR® criteria ≤3 months prior to screening
- •The patient smokes >20 cigarettes per day
- •Other protocol-defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Lu AF35700 oral solution (1 mg/mL)
Experimental
Planned daily doses range from 5 mg/day to 30 mg/day for 3 weeks. Weekly doses up to 75 mg/week for 3 weeks.
干预措施: Lu AF35700 (Drug)
Matching placebo
Placebo Comparator
Oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in AIMS, BARS and SAS Total score
时间窗: Baseline to day 21
Abnormal movement rating scale
Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: Sceening to day 78 (up to 8 weeks after last dose)
Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG)
时间窗: Screening to day 78 (up to 8 weeks after last dose)
次要结局
- Day 21 area under the Lu AF35700 and Lu AF36152 plasma concentration-time curve from 0-24 hours post dose (AUC0-tau) in a daily dosing regime(Day 21 in the dosing period)
- Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152(Day 1 and 21 in the dosing period)
- Half-lives (t½) of Lu AF35700 and Lu AF36152(Day 1 and 21 in the dosing period)
- Day 14-21 area under the Lu AF35700 and LuAF36152 plasma-concentration-time curve from 0-168 hours post-dose (AUCtau) in a weekly dosing regimen(Day 14-21 in the dosing period)
研究者
研究点 (1)
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