A Multiple Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ABT-652 Administered Once Daily to Subjects With an Excessive Daytime Sleepiness Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Laboratory Tests
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness. Subjects will be randomized to either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.
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
- Triple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
干预措施: ABT-652 (Drug)
Arm 1
ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
干预措施: Placebo (Drug)
Arm 2
ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
干预措施: ABT-652 (Drug)
Arm 2
ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
干预措施: Placebo (Drug)
Arm 3
ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days
干预措施: ABT-652 (Drug)
Arm 3
ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Laboratory Tests
时间窗: Baseline period to end of 1-week treatment period.
ECG
时间窗: Baseline period to end of 1-week treatment period.
Adverse Events
时间窗: Baseline period till 30 days after the last dose.
Vital Signs
时间窗: Baseline period to end of 1-week treatment period.
次要结局
- Maintenance Wakefulness Test(Baseline period to end of 1-week treatment period.)