Interventional, Randomised, Double-blind, Placebocontrolled, Single- and Multiple-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in healthy young Japanese men in comparison with Caucasian men.
详细描述
The study will be conducted in two parts.
Part A consists of two cohorts (named cohort A1 and A2), which are randomised, double-blind, parallel-group, placebo-controlled, single- and multiple dose regimens investigating the safety, tolerability, and pharmacokinetics of Lu AE58054 in healthy young men.
Part B consists of one cohort, B1, which is a randomised, open-label, two-way cross-over, single dose investigation of the effect of food on the pharmacokinetics of Lu AE58054 in healthy young Japanese men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese (Japanese passport, four Japanese grandparents, and lives outside Japan for less than 5 years) or Caucasian men aged 20 to 45 years with a BMI between 18 and 25 kg/m2 (extremes included).
排除标准
- •The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Cohort A1: Lu AE58054 or placebo
干预措施: Cohort A1: Lu AE58054 or placebo (Drug)
Cohort A2: Lu AE58054 or placebo
干预措施: Cohort A2: Lu AE58054 or placebo (Drug)
Cohort B1: Lu AE58054
干预措施: Cohort B1: Lu AE58054 (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: Up to Day 13
Adverse event monitoring
Number and frequency of adverse events
时间窗: Up to Day 13
Standard clinical safety assessments
次要结局
- Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau)(Day 9)
- Risk of Suicidality(Up to Day 13)
- Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf)(Day 1)
- Maximum observed concentration (Cmax) and time of observation (tmax)(Day 1 and Day 9)
- Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½)(Day 1 and Day 9)
- Accumulation index following multiple dosing of Lu AE58054 (AI)(Day 9)