An Open Label, Parallel-group Study to Determine Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment Compared to Matched Healthy Subjects With Normal Renal Function
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- CL/F After Multiple Dose Administration (Day 5)
研究概览
简要总结
An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched 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 65 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
Renal Impaired Subjects
once daily administration of 400 mg LCZ696 for 5 days
干预措施: LCZ696A (Drug)
Healthy Volunteers
once daily administration of 400 mg LCZ696 for 5 days
干预措施: LCZ696A (Drug)
结局指标
主要结局
CL/F After Multiple Dose Administration (Day 5)
时间窗: 5 days
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
时间窗: 1 and 5 days
T1/2 After Multiple Dose Administration (Day 5)
时间窗: 5 days
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
时间窗: 1 and 5 days
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
时间窗: 1 and 5 days
CLr After Multiple Dose Administration (Day 5)
时间窗: 5 days
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
次要结局
- 24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers(5 days)