Effect of Food on the Pharmacokinetics of LY2835219 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms
研究概览
简要总结
Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. 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
- 主要目的
- Basic Science
- 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
- •Healthy sterile males or surgically sterile or postmenopausal females
- •Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
- •Are able to eat a high-fat, high-calorie meal
排除标准
- •Participated in a clinical trial involving investigational product within 30 days
- •Abnormal blood pressure
- •Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Have donated blood of more than 500 milliliter (mL) within the last month
- •Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C
研究组 & 干预措施
LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
干预措施: LY2835219 (Drug)
LY2835219 Standard
Single oral dose of LY2835219 given with a standard meal in one of three study periods.
干预措施: LY2835219 (Drug)
LY2835219 Fasted
Single oral dose of LY2835219 given with no food in one of three periods.
干预措施: LY2835219 (Drug)
结局指标
主要结局
Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms
时间窗: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms
时间窗: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms
时间窗: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
次要结局
- Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm(Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period)
- Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm(Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period)
- Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm(Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period)
- Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)(Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period)