Effect of Evacetrapib on the Pharmacokinetics of Digoxin 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 (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin
研究概览
简要总结
The main purpose of this study is to determine how much digoxin gets into the blood stream and how long it takes the body to get rid of it when given with the study drug evacetrapib. This study will also look at the effect of evacetrapib on the removal of digoxin from the body by the kidneys. Information about any side effects that may occur will be collected. This study will last approximately 33 days for each participant, not including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Overtly healthy males and females (of non-childbearing potential)
- •Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
- •Normal renal function
排除标准
- •Participants who currently smoke or use tobacco or nicotine products
研究组 & 干预措施
Digoxin
0.5 milligram (mg) digoxin administered orally once daily (QD) on Day 1
干预措施: Digoxin (Drug)
Evacetrapib + Digoxin
130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15
干预措施: Evacetrapib (Drug)
Evacetrapib + Digoxin
130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15
干预措施: Digoxin (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin
时间窗: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of Digoxin
时间窗: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin
PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
时间窗: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin
次要结局
- Renal Clearance (CLr) of Digoxin(Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin)