An Open Label, Parallel-group Study to Determine Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Mild and Moderate Renal Impairment Compared to Matched Healthy Subjects With Normal Renal Function

Novartis Pharmaceuticals1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2009年2月最近更新: 2015年10月19日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 32
试验地点: 1
主要终点: Area Under the Concentration-time Curve (AUC0-24) From Time Zero to 24- Hour Post-dose (Day 1), and After Multiple Dose Administration (Day 5)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety of LCZ696 in this population.

研究设计

研究类型: Interventional
分配方式: Na
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 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male, and female subjects of non-child bearing potential,
•Subjects were to weigh at least 50 kg to participate in the study,
•and body mass index < 40 kg/m2
•Subjects were able to communicate well with the investigator, to understand and comply with the requirements of the study;
•Subjects were able to understand and sign the written informed consent;
•For renal insufficient subjects:
•stable renal disease without evidence of renal progressive
•mild renal function: calculated CrCl of 50-≤80 mL/min
•moderate renal function: calculated CrCl of 30-<50 mL/min
•Vital signs:
•oral body temperature between 35.0-37.8 °C
•systolic blood pressure, 95-180 mm Hg
•diastolic blood pressure, 60-110 mm Hg
•pulse rate, 54-95 bpm
•For healthy subjects only
•A serum creatinine with a calculated CrCl of >80 mL/min
•Vital signs:
•oral body temperature between 35.0-37.2 °C
•systolic blood pressure, 95-140 mm Hg
•diastolic blood pressure, 60-100 mm Hg
•pulse rate, 45-90 bpm

排除标准

•Current use of ACE inhibitors, valsartan, and drugs that were known as CYP2C9 substrates, potassium-sparing diuretics;
•History of renal transplant at any time in the past and on immunosuppressant therapy;
•Dialysis patients;
•Medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome;
•Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance; Other protocol defined inclusion/exclusion criteria may apply

研究组 & 干预措施

LCZ696 400 mg

Experimental

LCZ696 400 mg once daily for 5 days

干预措施: LCZ696 (Drug)

结局指标

主要结局

Area Under the Concentration-time Curve (AUC0-24) From Time Zero to 24- Hour Post-dose (Day 1), and After Multiple Dose Administration (Day 5)

时间窗: Day 1 and day 5