An Evaluation of the Impact of Single Doses of LY3154207 on Sleep Latency in Sleep-Deprived Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Time to Sleep Onset
研究概览
简要总结
This study will evaluate the effect of single doses of LY3154207 on the amount of time it takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much LY3154207 gets into the blood stream and how long it takes the body to remove it. Information about any side effects that occur will be collected. Each participant will complete four study periods, which will last a total of about 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males 18 years of age or older who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- •Have a regular sleep pattern with routine time spent in bed between 6.5 hours and 9 hours each night
排除标准
- •Are shift workers who shifted work within 14 days prior to screening or plan to during the study
- •Have a known sleep disorder or history of a sleep disorder
- •Have traveled 2 time zones or more within 7 days prior to screening or plan to during the study
- •Regularly take naps during the day
- •Are hearing impaired
研究组 & 干预措施
Placebo
Placebo matching LY3154207 administered once orally in one of four periods.
干预措施: Placebo (Drug)
LY3154207 - Dose 1
LY3154207 administered orally in no more than one of the four periods.
干预措施: LY3154207 (Drug)
LY3154207 - Dose 2
LY3154207 administered orally in no more than one of the four periods.
干预措施: LY3154207 (Drug)
LY3154207 - Dose 3
LY3154207 administered orally in no more than one of the four periods.
干预措施: LY3154207 (Drug)
Modafinil
200 mg modafinil administered orally in no more than one of the four periods.
干预措施: Modafinil (Drug)
结局指标
主要结局
Time to Sleep Onset
时间窗: Day 1: 2 hours post dose through 8 hours post dose in each period.
次要结局
- Maximum Concentration (Cmax) of LY3154207(Day 1: 1 hour post dose through 24 hours post dose in each period.)
- Area Under the Concentration Versus Time Curve (AUC) of LY3154207(Day 1: 1 hour post dose through 24 hours post dose in each period.)