A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Circadian Phase Shift
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No medical, psychiatric, or sleep disorders
- •Ability to provide written informed consent
排除标准
- •Lifetime history of night shift work
- •Evidence of any sleep disorder
- •Psychiatric or neurological disorders
结局指标
主要结局
Circadian Phase Shift
时间窗: Night 3 and Night 4
Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.
Mean Sleep Efficiency
时间窗: Night 4 and Night 2
Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.
次要结局
- VEC-162 AUC(Night 4)
- VEC-162 Cmax(Night 4)
- VEC-162 Tmax(Night 4)
- Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)(Night 2 and Night 4)