A Phase I, Randomized Double-blind, Placebo-controlled, Single-center, Single-dose, Three-way Cross-over Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Lacosamide Tablets in Healthy Male Chinese and Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 33
- 主要终点
- Maximum drug concentration (Cmax) of lacosamide in plasma.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Chinese or Japanese volunteers
排除标准
- •Subject has participated or is participating in any other clinical studies of Lacosamide within the last 3 months
- •Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any psychological or emotional problems, a drug/alcohol abuse, abnormal diet, having abnormal safety parameters)
研究组 & 干预措施
Lacosamide 100 mg, Japanese
1 Lacosamide 100 mg tablet plus 3 placebo tablets
干预措施: Lacosamide (Drug)
Lacosamide 100 mg, Japanese
1 Lacosamide 100 mg tablet plus 3 placebo tablets
干预措施: Placebo 3 (Other)
Lacosamide 100 mg, Chinese
1 Lacosamide 100 mg tablet plus 3 placebo tablets
干预措施: Lacosamide (Drug)
Lacosamide 100 mg, Chinese
1 Lacosamide 100 mg tablet plus 3 placebo tablets
干预措施: Placebo 3 (Other)
Lacosamide 200 mg, Japanese
2 Lacosamide 100 mg tablets plus 2 placebo tablets
干预措施: Lacosamide (Drug)
Lacosamide 200 mg, Japanese
2 Lacosamide 100 mg tablets plus 2 placebo tablets
干预措施: Placebo 2 (Other)
Lacosamide 200 mg, Chinese
2 Lacosamide 100 mg tablets plus 2 placebo tablets
干预措施: Lacosamide (Drug)
Lacosamide 200 mg, Chinese
2 Lacosamide 100 mg tablets plus 2 placebo tablets
干预措施: Placebo 2 (Other)
Lacosamide 400 mg, Japanese
4 Lacosamide 100 mg tablets
干预措施: Lacosamide (Drug)
Lacosamide 400 mg, Chinese
4 Lacosamide 100 mg tablets
干预措施: Lacosamide (Drug)
Placebo Comparator, Japanese
4 placebo tablets
干预措施: Placebo 4 (Other)
Placebo Comparator, Chinese
4 placebo tablets
干预措施: Placebo 4 (Other)
结局指标
主要结局
Maximum drug concentration (Cmax) of lacosamide in plasma.
时间窗: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of lacosamide in plasma
时间窗: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of lacosamide in plasma
时间窗: Multiple sampling from 0 to 72 hours following single dose in each treatment period
次要结局
- Time to reach maximum plasma concentration (tmax) of lacosamide in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Terminal half-life (t½) of lacosamide in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Apparent total body clearance (CL/F) of lacosamide in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Apparent volume of distribution (Vz/F) of lacosamide in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Mean resident time (MRT) of lacosamide in plasma.(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- First order terminal elimination rate constant (λZ ) of lacosamide in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Maximum drug concentration (Cmax) of SPM12809 in plasma.(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Terminal half-life (t½) of SPM12809 in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- First order terminal elimination rate constant (λZ ) of SPM12809 in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Fraction of dose excreted in urine (fe) of lacosamide and SPM12809(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Renal clearance (CLR) of lacosamide and SPM12809(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Apparent formation clearance of metabolites (CLfm/F)(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- AUC Ratio(Multiple sampling from 0 to 72 hours following single dose in each treatment period)