A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- PK Parameters of Evacetrapib: Maximum Concentration (Cmax)
研究概览
简要总结
The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected.
This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:
- •Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
- •Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
- •Hypercholesterolemia on stable statin therapy for at least 3 month
- •Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening
排除标准
- •Have known allergies or intolerance to evacetrapib, related compounds
- •Have history of recurrent rashes or chronic skin conditions
- •Have significant history of or current chronic, active inflammatory conditions
- •Have history or current evidence of significant neurological disorder
- •Have long-standing diabetes that is insulin requiring
- •Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery
研究组 & 干预措施
Evacetrapib: Single Dose
Single oral dose of evacetrapib on Day 1
干预措施: Evacetrapib (Drug)
Evacetrapib: Multiple Dose 12 Weeks
Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
干预措施: Evacetrapib (Drug)
Evacetrapib: Multiple Dose 24 Weeks
Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks
干预措施: Evacetrapib (Drug)
Evacetrapib: Multiple Dose 52 Weeks
Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks
干预措施: Evacetrapib (Drug)
结局指标
主要结局
PK Parameters of Evacetrapib: Maximum Concentration (Cmax)
时间窗: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
PK Parameters of Evacetrapib: Terminal Half-life
时间窗: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast])
时间窗: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
次要结局
- PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level(Day -1, Day 8)
- PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level(Day -1, Day 8)
- PD Parameters of Evacetrapib: Total Cholesterol Level(Day -1, Day 8)
- PD Parameters of Evacetrapib: Triglyceride Level(Day -1, Day 8)