A Single-Dose Pharmacokinetic Study of Abemaciclib (LY2835219) in Subjects With Varying Degrees of Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites
研究概览
简要总结
The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated.
This study will last approximately 3 weeks for each participant, including check-in and follow-up.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female participants must be of non-child-bearing potential
- •Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)
排除标准
- •No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders
- •Have known allergies to abemaciclib, related compounds, or any components of the formulation
- •No human immunodeficiency virus (HIV) infection or antibodies
研究组 & 干预措施
Abemaciclib: Normal Hepatic Function
Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function.
干预措施: Abemaciclib (Drug)
Abemaciclib: Mild Hepatic Impairment
Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment.
干预措施: Abemaciclib (Drug)
Abemaciclib: Moderate Hepatic Impairment
Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment.
干预措施: Abemaciclib (Drug)
Abemaciclib: Severe Hepatic Impairment
Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment.
干预措施: Abemaciclib (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites
时间窗: Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites
时间窗: Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose
次要结局
未报告次要终点