Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2811376 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Clinical Effects
研究概览
简要总结
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2811376 single doses, how the body handles the drug, and the drug's effect on the body.
详细描述
This is a Phase 1 study with 2 parts, both in healthy subjects. Part 1 is a subject- and investigator-blind, placebo-controlled, randomized, 3 period, crossover study. Part 1 will assess the safety and tolerability of LY2811376 single doses, how the body handles the drug, and the drug's effect on the body. Part 2 is a subject- and investigator-blind, placebo-controlled, randomized study to assess the safety and tolerability of a LY2811376 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and nonchild-bearing potential women
- •20 years or older
- •Body mass index between 18-32kg/m2
排除标准
- •Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement.
- •Smoke more than 10 cigarettes per day.
- •Consume more than 5 cups of coffee per day.
研究组 & 干预措施
LY2811376 Part 1
LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods.
干预措施: LY2811376 (Drug)
Placebo Part 1
once a day or twice a day for 1 day in up to 3 periods.
干预措施: Placebo (Drug)
LY2811376 - Part 2 low dose
Single dose of LY2811376, dose determined by part 1
干预措施: LY2811376 (Drug)
LY2811376 - Part 2 high dose
Single dose of LY2811376, dose determined by part 1
干预措施: LY2811376 (Drug)
Placebo Part 2
single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Effects
时间窗: Predose and up to Day 6 of each period
次要结局
- Plasma concentration of LY2811376 (Cmax)(Predose and up to Day 6 of each period)
- Plasma concentration of LY2811376 (AUC)(Predose and up to Day 6 of each period)
- Amyloid beta 1-40 plasma concentrations(Predose and up to Day 6 of each period)
- Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)(Predose and up to 36 hours)
- Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)(Predose and up to 36 hours)
- Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)(Predose and up to 36 hours)