Single- and Multiple-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically Significant Effects
研究概览
简要总结
The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, to evaluate how the body handles the drug, and to evaluate 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 (BMI) between 18.0 and 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
Placebo
Single oral dose and/or once daily (QD) oral dosing for 14 consecutive days
干预措施: Placebo (Drug)
35 mg LY2886721
QD oral dosing for 14 consecutive days
干预措施: LY2886721 (Drug)
70 mg LY2886721
Single oral dose or single oral dose followed by QD oral dosing for 14 consecutive days
干预措施: LY2886721 (Drug)
140 mg LY2886721
Single oral dose
干预措施: LY2886721 (Drug)
结局指标
主要结局
Number of Participants With Clinically Significant Effects
时间窗: Predose up to Day 23
Data presented are the number of participants who experienced treatment-emergent adverse events. A summary of serious adverse events and other non-serious adverse events, regardless of causality is reported in the Adverse Events module.
次要结局
- Pharmacokinetics: Plasma Maximum Observed Concentration (Cmax) of LY2886721(Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose)
- Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of LY2886721(Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose)
- Pharmacokinetics: Plasma Maximum Observed Concentration at Steady State (Cmax,ss) of LY2886721(Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose)
- Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721(Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose)
- Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at Day 15(Baseline, Day 15)
- Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at 24 Hours Post-dose(Baseline, 24 hours post-dose)