Effect of Food on the Pharmacokinetics of LY2157299 Monohydrate in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299
研究概览
简要总结
Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken at least 4 days apart. One dose will be given without food. One dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 15 days not including screening. Screening is required within 30 days prior to the start of the study.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy sterile males or females
- •Are able to eat a high fat meal
- •No abnormal heart function or high blood pressure
- •No participation in a clinical trial within 30 days
- •No evidence of human deficiency virus (HIV), hepatitis C or hepatitis B
排除标准
- •Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
研究组 & 干预措施
LY2157299 (Fasted)
Single dose of 150 mg LY2157299 administered orally in fasted state in one of two study periods.
干预措施: LY2157299 (Drug)
LY2157299 (Fed)
Single dose of 150 mg LY2157299 administered orally in fed state in one of two study periods.
干预措施: LY2157299 (Drug)
结局指标
主要结局
Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299
时间窗: Pre-dose through 72 hours post-dose in each study period
Pharmacokinetics: Time of Maximum Observed Concentration (tmax) of LY2157299
时间窗: Pre-dose through 72 hours post-dose in each study period
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2157299
时间窗: Pre-dose through 72 hours post-dose in each study period
次要结局
未报告次要终点