A Phase 1, Randomized, Double-blind, Double-dummy, Placebo-controlled, 5-period, Crossover Study Assessing the Effects of Rapastinel Compared to Alprazolam, Ketamine, and Placebo on Simulated Driving Performance in Normal Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with placebo and positive control (alprazolam)
研究概览
简要总结
Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the participant's driving performance after single IV doses of rapastinel as compared with single oral doses of alprazolam, a benzodiazepine that demonstrates driving impairment, and placebo in 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
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rapastinel High Dose
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
干预措施: Rapastinel (Drug)
Rapastinel Low Dose
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
干预措施: Rapastinel (Drug)
Alprazolam
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
干预措施: Alprazolam (Drug)
Ketamine
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
干预措施: Ketamine (Drug)
Placebo for Rapastinel
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
干预措施: Rapastinel Matched Placebo (Drug)
Placebo for Alprazolam
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
干预措施: Alprazolam Matched Placebo (Drug)
Placebo for Ketamine
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
干预措施: Ketamine Matched Placebo (Drug)
结局指标
主要结局
Simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with placebo and positive control (alprazolam)
时间窗: Day 1 of each intervention
次要结局
- Divided attention: average reaction time(Day 1 of each intervention)
- Adverse Events(Up to 66 days)
- Proportion of abnormal electrocardiograms(Up to 66 days)
- Karolinska Sleepiness Scale (KSS)(Day 1 of each intervention)
- Self-perceived safety to drive ("Right now do you feel safe to drive?)(Day 1 of each intervention)
- CogScreen SDC Test(Day 1 of each intervention)
- Average Speed (mph)(Day 1 of each intervention)
- Divided attention: average number of errors(Day 1 of each intervention)
- simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with a clinical comparator (ketamine)(Day 1 of each intervention)
- Number of exceeded cornering speed threshold events(Day 1 of each intervention)
- Rapastinel blood plasma concentration(Day 1 of each intervention)
- Visual Analog Scale to assess participant's motivation and self-appraisal of their driving performance(Day 1 of each intervention)
- Proportion of abnormal lane exceedance events(Day 1 of each intervention)
- Total collisions(Day 1 of each intervention)
- Divided attention: average number of correct responses(Day 1 of each intervention)
- Columbia-Suicide Severity Rating Scale(Up to 66 days)