Relative Bioavailability and the Effect of Food on the Bioavailability of LY2801653 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Maximum Concentration (Cmax) for LY2801653
研究概览
简要总结
The purpose of this study is to evaluate how much of the LY2801653 drug is available in the body when given in 2 different formulations with and without a meal to healthy participants who are not able to have children. In addition, this study will measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study will last about 27 days. Screening is required within 28 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
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy sterile male and female participants
- •Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive
- •Are willing and able to eat the protocol specified high-fat breakfast
排除标准
- •Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange juice, star fruit, star fruit juice, or star fruit-containing products, or commercial apple or orange juice within 14 days prior to first dosing
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- •Have donated blood of more than 500 milliliter (mL) within the last month
研究组 & 干预措施
LY2801653 Reference - Fasted
Single oral dose of LY2801653 (Reference Formulation) administered in fasted state in one of three study periods.
干预措施: LY2801653 (Drug)
LY2801653 Test - Fasted
Single oral dose of LY2801653 (Test Formulation) administered in fasted state in one of three study periods.
干预措施: LY2801653 (Drug)
LY2801653 Test - Fed
Single oral dose of LY2801653 (Test Formulation) administered with a high fat meal in one of three study periods.
干预措施: LY2801653 (Drug)
结局指标
主要结局
Pharmacokinetics: Maximum Concentration (Cmax) for LY2801653
时间窗: Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653
时间窗: Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
次要结局
- Pharmacokinetics: Maximum Concentration (Cmax) of LY2801653 and Major Metabolites LSN2800870 and LSN2887652(Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3)
- Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 and Major Metabolites LSN2800870 and LSN2887652(Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3)