Evaluation of the Impact of Increased Gastric pH Following Omeprazole Administration on the Pharmacokinetics of Evacetrapib in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib
研究概览
简要总结
The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.
There are two parts to the study. Participation in both parts will be required.
The study will last approximately 30 days, 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 participants, as determined by medical history and physical examination
- •Females must be of non-child-bearing potential
- •Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
排除标准
- •Have known allergies to evacetrapib, omeprazole, related compounds, or any components of the evacetrapib or omeprazole formulations
研究组 & 干预措施
Evacetrapib
Single oral dose of evacetrapib administered alone on Day 1 of Period 1.
干预措施: Evacetrapib (Drug)
Omeprazole + Evacetrapib
In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20.
Evacetrapib will be co-administered once, orally on Day 14.
干预措施: Evacetrapib (Drug)
Omeprazole + Evacetrapib
In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20.
Evacetrapib will be co-administered once, orally on Day 14.
干预措施: Omeprazole (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib
时间窗: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
时间窗: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
时间窗: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
次要结局
未报告次要终点