A Phase I, Open Label, Multicenter, Parallel-group, Single Dose Two-staged Study to Evaluate the Pharmacokinetics and Safety of a Single 400 mg Oral Dose of LEE011 in Subjects With Varying Degrees of Impaired Renal Function Compared to Matched Healthy Volunteers With Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Primary Pharmacokinetics (PK) parameters of LEE011 when appropriate
研究概览
简要总结
The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Normal renal function
Normal renal function; matched demography to renal impariment cohorts
干预措施: LEE011 (Drug)
Severe renal impairment
Severe decrease in GFR (15-29 ml/min)
干预措施: LEE011 (Drug)
End Stage Renal Disease
End stage renal disease not on dialysis; GFR <15 ml/min
干预措施: LEE011 (Drug)
Mild renal impairment
Mild decrease in GFR (60-89 ml/min)
干预措施: LEE011 (Drug)
Moderate renal impairment
Moderate decrease in GFR (30-59 ml/min)
干预措施: LEE011 (Drug)
结局指标
主要结局
Primary Pharmacokinetics (PK) parameters of LEE011 when appropriate
时间窗: 14 days
Primary composite PK parameters: Cmax, AUClast, AUCinf, and CL/F. To determine the impact of various degrees of renal impairment on primary PK parameters of LEE011 following a single 400mg oral dose
次要结局
- Frequency of adverse events (AEs)(From consent to 28 days post-dose)
- PK parameters of LEQ803 (i.e., Cmax, AUClast, AUCinf, Tmax, T1/2)(14 days)
- Secondary PK parameters of LEE011 when appropriate(14 days)