Single-Ascending 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
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically Significant Effects (Adverse Events)
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 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 LY2886721 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 an LY2886721 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 —（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 18-32 kilograms per square meter (kg/m^2)
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
研究组 & 干预措施
LY2886721 Part 1: Cohort A/B
Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods
干预措施: LY2886721 (Drug)
Placebo Part 1: Cohort A/B
Single dose in up to 1 period
干预措施: Placebo (Drug)
LY2886721 Part 2: Cohort C
Single 10 mg dose of LY2886721, dose determined by Part 1
干预措施: LY2886721 (Drug)
LY2886721 Part 2: Cohort D
Single 35 mg dose of LY2886721, dose determined by Part 1
干预措施: LY2886721 (Drug)
Placebo Part 2: Cohort C/D
Single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Clinically Significant Effects (Adverse Events)
时间窗: Predose to 10-14 days after final dose of study drug (up to 42 days)
A summary of serious adverse events and other nonserious adverse events located in Reported Adverse Event section. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in other LY2886721 groups received LY2886721 in fasted state. Due to crossover design in Part 1, results reported by treatment; thus, participants are included in multiple arms.
次要结局
- Maximum Observed Plasma Concentration (Cmax) of LY2886721(0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose)
- Plasma Concentration of LY2886721: Area Under the Concentration Versus Time Curve (AUC)(0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose)
- Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only)(0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose)
- Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only)(Predose and up to 36 hours postdose)
- Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only)(Predose and up to 36 hours postdose)
- Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only)(Predose and up to 36 hours postdose)