A Randomized, Double-blind, 3-Period Crossover Study to Assess the Effects of MK-6552 on Sleep Latency in Sleep Deprived Healthy Participants With Modafinil as a Positive Control
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Participants with an Adverse Event (AE)
研究概览
简要总结
This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Criteria include but are not limited to the following:
- •Is in good health
- •Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive.
排除标准
- •Criteria include but are not limited to the following:
- •History of or current hypertension,
- •Has a history of sleep disorders:
研究组 & 干预措施
Placebo-Modafinil-MK-6552
Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with Modafinil; and in period 3 with MK-6552; with a 7-day washout between each period.
干预措施: MK-6552 (Drug)
MK-6552-Modafinil-Placebo
Participants were treated in period 1 with MK-6552; in period 2 with Modafinil; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.
干预措施: Modafinil placebo (Drug)
MK-6552-Placebo-Modafinil
Participants were treated in period 1 with MK-6552; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.
干预措施: MK-6552 (Drug)
MK-6552-Placebo-Modafinil
Participants were treated in period 1 with MK-6552; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.
干预措施: MK-6552 placebo (Drug)
MK-6552-Placebo-Modafinil
Participants were treated in period 1 with MK-6552; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.
干预措施: Modafinil (Drug)
MK-6552-Placebo-Modafinil
Participants were treated in period 1 with MK-6552; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.
干预措施: Modafinil placebo (Drug)
MK-6552-Modafinil-Placebo
Participants were treated in period 1 with MK-6552; in period 2 with Modafinil; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.
干预措施: MK-6552 (Drug)
MK-6552-Modafinil-Placebo
Participants were treated in period 1 with MK-6552; in period 2 with Modafinil; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.
干预措施: MK-6552 placebo (Drug)
MK-6552-Modafinil-Placebo
Participants were treated in period 1 with MK-6552; in period 2 with Modafinil; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.
干预措施: Modafinil (Drug)
Placebo-Modafinil-MK-6552
Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with Modafinil; and in period 3 with MK-6552; with a 7-day washout between each period.
干预措施: MK-6552 placebo (Drug)
Placebo-Modafinil-MK-6552
Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with Modafinil; and in period 3 with MK-6552; with a 7-day washout between each period.
干预措施: Modafinil (Drug)
Placebo-Modafinil-MK-6552
Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with Modafinil; and in period 3 with MK-6552; with a 7-day washout between each period.
干预措施: Modafinil placebo (Drug)
Placebo-MK-6552-Modafinil
Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.
干预措施: MK-6552 (Drug)
Placebo-MK-6552-Modafinil
Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.
干预措施: MK-6552 placebo (Drug)
Placebo-MK-6552-Modafinil
Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.
干预措施: Modafinil (Drug)
Placebo-MK-6552-Modafinil
Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.
干预措施: Modafinil placebo (Drug)
Modafinil-MK-6552-Plaebo
Participants were treated in period 1 with Modafinil; in period 2 withMK-6552; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.
干预措施: MK-6552 (Drug)
Modafinil-MK-6552-Plaebo
Participants were treated in period 1 with Modafinil; in period 2 withMK-6552; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.
干预措施: MK-6552 placebo (Drug)
Modafinil-MK-6552-Plaebo
Participants were treated in period 1 with Modafinil; in period 2 withMK-6552; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.
干预措施: Modafinil (Drug)
Modafinil-MK-6552-Plaebo
Participants were treated in period 1 with Modafinil; in period 2 withMK-6552; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.
干预措施: Modafinil placebo (Drug)
Modafinil-Plaebo-MK-6552
Participants were treated in period 1 with Modafinil; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with MK-6552; with a 7-day washout between each period.
干预措施: MK-6552 (Drug)
Modafinil-Plaebo-MK-6552
Participants were treated in period 1 with Modafinil; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with MK-6552; with a 7-day washout between each period.
干预措施: MK-6552 placebo (Drug)
Modafinil-Plaebo-MK-6552
Participants were treated in period 1 with Modafinil; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with MK-6552; with a 7-day washout between each period.
干预措施: Modafinil (Drug)
Modafinil-Plaebo-MK-6552
Participants were treated in period 1 with Modafinil; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with MK-6552; with a 7-day washout between each period.
干预措施: Modafinil placebo (Drug)
结局指标
主要结局
Participants with an Adverse Event (AE)
时间窗: Up to Day 30
Percentage of participants with at least one AE
Participants who discontinued from study due to an AE
时间窗: Day 1
Percentage of participants who discontinued from study due to an AE
Maintenance of Wakefulness Test (MWT) for MK-6552
时间窗: Postdose time to maximum plasma concentration (Tmax) (at designated timepoints up to 24 hours postdose)
Sleep latency of MWT for MK-6552 compared with placebo
次要结局
- Concentration of plasma MK-6552 8 hours (C8h) after first dose(8 hours)
- Concentration of plasma MK-6552 24 hours (C24h) after first dose(24 hours)
- MWT for Modafinil(2 hours postdose)
- Area under the concentration=time curve (AUC) for plasma MK-6552(At designated timepoints up to 24 hours postdose)
- Concentration of plasma MK-6522 at Tmax following morning (AM) dose(Tmax following AM dose (at designated timepoints up to 24 hours postdose))
- Concentration of plasma MK-6522 at Tmax following afternoon (PM) dose(Tmax following PM dose (at designated timepoints up to 24 hours postdose))