A Phase 1 Study in Healthy Subjects to Determine the Safety, Tolerability, Psychomotor Function and Cognitive Effects of Perampanel When Administered With Alcohol
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 主要终点
- Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone
研究概览
简要总结
A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor function, and cognitive effects of perampanel when administered alone and with alcohol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
alcohol + placebo
Part A alcohol + placebo
干预措施: alcohol + placebo (Drug)
alcohol + perampanel
Part A : alcohol + perampanel
干预措施: alcohol + perampanel (Drug)
perampanel + alcohol
Part B: perampanel + alcohol
干预措施: perampanel + alcohol (Drug)
placebo + alcohol
Part B: placebo + alcohol
干预措施: placebo + alcohol (Drug)
结局指标
主要结局
Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone
时间窗: Part B Day 34
Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel alone
时间窗: baseline to Part A Day 1
Part B: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]) due to perampanel and alcohol combined and perampanel alone
时间窗: baseline to Part B Day 62
Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone
时间窗: baseline to Part B Day 62
次要结局
- Part A: Incidence of AEs when perampanel is administered in combination with alcohol(baseline to Part A Day 29)
- Part B: Incidence of AEs when perampanel is administered in combination with alcohol(baseline to Part B Day 62)