NCT01227252已完成1 期
Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects
适应症
干预措施
相关药物
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 Participants With Clinically Significant 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 LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and non-childbearing potential women
- •Body mass index between 18.0-32.0 kilograms per square meter (kg/m^2)
- •Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies
排除标准
- •Taking over-the-counter or prescription medication with the exception of vitamins or minerals
- •Smoke more than 10 cigarettes per day
- •Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day
研究组 & 干预措施
LY2886721
Experimental
干预措施: LY2886721 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Clinically Significant Effects
时间窗: Predose up to Day 70
Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure.
次要结局
- Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721(Predose (Day 14) to 24 Hours post-dose (Day 15))
- Plasma Amyloid Beta (Aβ) 1-40 Concentration(Predose (Day 14) up to Day 19)
- Cerebrospinal Fluid (CSF) Concentration of LY2886721(24 Hours post-dose (Day 15))
- Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration(Predose (Day 14), 24 Hours post-dose (Day 15))
- Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721(Predose (Day 14) up to Day 19)
研究者
研究点 (1)
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