A Double-blind, Randomized, Placebo-controlled, Three-way Crossover Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Adaptive tracking from 60 minutes Pre-Dose up to 10 hours Post-Dose
研究概览
简要总结
To evaluate if Brivaracetam (BRV) influences the psychomotor and cognitive impairing effects of Ethanol
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers with the age between 18 and 55 years old
排除标准
- •Subject has participated or is participating in any other clinical studies of investigational drug or another investigational medical product within the last 3 months or has participated in 4 or more Investigational Medicinal Product (IMP) studies within 1 year prior to screening
- •Subject is not healthy (eg, taking any drug treatments except use of Paracetamol, excessive amount of alcohol, cigarettes, caffeine consumption, having a positive drug / alcohol abuse, having abnormal safety parameters)
- •Subject has not been vaccinated for hepatitis
- •Subjects has consumed any grapefruits, grapefruits juice, grapefruit-containing products or star fruit within 14 days prior to dosing or not able to refrain from these products during the study
- •Subject has Ethanol intolerance
- •Subject has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP)
- •Subject has made a blood donation or a comparable blood loss (500 ml) within the last 3 months prior to screening
- •subject is an employee of the investigator or study center or subject is a first line family member of an employee working in the respective study center or of the investigator
研究组 & 干预措施
Ethanol + Brivaracetam
Treatment A: Ethanol + Brivaracetam
干预措施: Brivaracetam (Drug)
Ethanol + Brivaracetam
Treatment A: Ethanol + Brivaracetam
干预措施: Ethanol (Other)
Ethanol Placebo + Brivaracetam
Treatment B: Ethanol Placebo + Brivaracetam
干预措施: Brivaracetam (Drug)
Ethanol Placebo + Brivaracetam
Treatment B: Ethanol Placebo + Brivaracetam
干预措施: Ethanol Placebo (Other)
Ethanol + Brivaracetam Placebo
Treatment C: Ethanol + Brivaracetam Placebo
干预措施: Ethanol (Other)
Ethanol + Brivaracetam Placebo
Treatment C: Ethanol + Brivaracetam Placebo
干预措施: Brivaracetam Placebo (Other)
结局指标
主要结局
Adaptive tracking from 60 minutes Pre-Dose up to 10 hours Post-Dose
时间窗: From 60 minutes Pre-Dose up to 10 hours Post-Dose
Performance will be scored after a fixed period of 3.5 minutes and reflected visuo motor control and vigilance. The average performance scores will be used in the analysis.
Visual Analog Scales for Alertness From 60 minutes Pre-Dose up to 10 hours Post-Dose
时间窗: From 60 minutes Pre-Dose up to 10 hours Post-Dose
Visual Analog Scales according to Bond and Lader
Visual Analog Scales for Calmness From 60 minutes Pre-Dose up to 10 hours Post-Dose
时间窗: From 60 minutes Pre-Dose up to 10 hours Post-Dose
Visual Analog Scales according to Bond and Lader
Saccadic Eye Movements from 60 minutes Pre-Dose up to 10 hours Post-Dose
时间窗: From 60 minutes Pre-Dose up to 10 hours Post-Dose
Average values of Latency (reaction time), Saccadic Peak Velocity, and Inaccuracy (difference between stimulus angle and corresponding saccade in percentages) will be calculated for all artifact-free saccades.
Body sway from 60 minutes Pre-Dose up to 10 hours Post-Dose
时间窗: From 60 minutes Pre-Dose up to 10 hours Post-Dose
The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. (antero-posterior sway in mm / 2 minutes)
Visual Verbal Learning Test from 1.5 hours Post-Dose up to 6 hours Post-Dose
时间窗: From 1.5 hours Post-Dose up to 6 hours Post-Dose
Immediate recall, immediate recognition, delayed recall, and delayed recognition to evaluate memory
Smooth pursuit eye movements from 60 minutes Pre-Dose up to 10 hours Post-Dose
时间窗: From 60 minutes Pre-Dose up to 10 hours Post-Dose
The time during which the eyes are in smooth pursuit of the target will be calculated for each frequency and expressed as a percentage of stimulus duration. The average percentage of smooth pursuit for all stimulus frequencies will be used as a parameter.
Visual Analog Scales for Mood From 60 minutes Pre-Dose up to 10 hours Post-Dose
时间窗: From 60 minutes Pre-Dose up to 10 hours Post-Dose
Visual Analog Scales according to Bond and Lader
Visual Analog Scale for alcohol intoxication From 60 minutes Pre-Dose up to 10 hours Post-Dose
时间窗: From 60 minutes Pre-Dose up to 10 hours Post-Dose
The scale consists of a 10 cm line anchored on the left end by "sober" and on the right end by "drunk." Subjects mark a point on the line that best represents their subjective state corresponding to the condition tested. The result is a distance calculated from the mark on the line.
次要结局
- Total Ethanol Dose analyzed by a model independent parameter estimate(From - 30 minutes Pre-Dose to 10 hours Post-Dose)
- The maximum plasma concentration (Cmax)(From Pre-Dose (- 5 minutes) to 36 hours Post-Dose)
- The area under the plasma concentration-time curve from zero to infinity (AUC)(From Pre-Dose (- 5 minutes) to 36 hours Post-Dose)
- The area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification [AUC(0-t)](From Pre-Dose (- 5 minutes) to 36 hours Post-Dose)
- The time to reach the maximum plasma concentration (tmax)(From Pre-Dose (- 5 minutes) to 36 hours Post-Dose)
- The terminal disposition rate constant (λz) with the respective terminal half-life (t1/2)(From Pre-Dose (- 5 minutes) to 36 hours Post-Dose)
- Breath Ethanol concentrations(From - 30 minutes Pre-Dose to 10 hours Post-Dose)
- Serum Ethanol concentrations(From - 30 minutes Pre-Dose to 10 hours Post-Dose)