Pharmacokinetics of Evacetrapib (LY2484595) in Subjects With Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
研究概览
简要总结
The purpose of this study is to measure how much of the drug gets into the bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal hepatic function. Information about any side effects that may occur will also be collected. This study will last approximately 28 days, not including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants have given written informed consent approved by the ethical review board (ERB) governing the site
- •Female participants should be of non-childbearing potential
- •Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m^2)
- •Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures
- •Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)
排除标准
- •Has had esophagus variceal bleeding within 3 months of check-in
- •Have the need to take medications that may interfere with how the liver removes the drug
- •Have evidence of cancer in the liver
- •Consumes excessively large amounts of drinks with caffeine or alcohol
研究组 & 干预措施
Evacetrapib (Healthy)
Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function
干预措施: Evacetrapib (Drug)
Evacetrapib (Hepatic, Mild)
Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment
干预措施: Evacetrapib (Drug)
Evacetrapib (Hepatic, Moderate)
Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment
干预措施: Evacetrapib (Drug)
Evacetrapib (Hepatic, Severe)
Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment
干预措施: Evacetrapib (Drug)
结局指标
主要结局
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
时间窗: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib
时间窗: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose
tlast is defined as the last time point with a measurable concentration of Evacetrapib.
PK: Maximum Observed Concentration (Cmax) of Evacetrapib
时间窗: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose
次要结局
未报告次要终点