A Single-dose, Open-label Parallel-group Study to Assess the Pharmacokinetics of LCZ696 in Subjects With Hepatic Impairment Compared to Matched Healthy Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)
研究概览
简要总结
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •All subjects:
- •Male and female subjects aged 18-75 years.
- •Body weight at least 55 kg with a body mass index between 18-35 kg/m
- •Hepatic impairment subjects:
- •Mild or moderate hepatic impairment.
排除标准
- •All subjects:
- •Clinical manifestations of postural symptomatic hypotension at screening or baseline.
- •History of hypersensitivity to LCZ696 or to drugs of similar classes.
- •Hepatic impairment subjects:
- •Hepatic impairment due to non-liver disease.
- •Treatment with any vasodilator, autonomic alpha blocker or beta2 agonist within 2 weeks of dosing.
- •Encephalopathyy Stage III or IV.
- •Primary biliary liver cirrhosis or biliary obstruction.
- •History of gastro-intestinal bleeding within 3 months prior to screening.
- •Healthy subjects:
- •Any surgical or medical condition which might significantly alter the distribution, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
- •Use of prescription drugs, herbal supplements, and/or over-the-counter medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Group 1: mild hepatic impairment
LCZ696 200 mg, given as a single oral dose
干预措施: LCZ696 (Drug)
Group 2: moderate hepatic impairment
LCZ696 200 mg, given as a single oral dose
干预措施: LCZ696 (Drug)
Group 3: healthy volunteers
LCZ696 200 mg, given as a single oral dose. Each healthy volunteer will match in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in groups 1 and 2
干预措施: LCZ696 (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)
时间窗: From pre-dose on Day 1 until 96h post-dose (Day 5)
Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)
时间窗: From pre-dose on Day 1 until 96h post-dose (Day 5)
Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing
Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan)
时间窗: From pre-dose on Day 1 until 96h post-dose (Day 5)
Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing
次要结局
- Number of Participants With Adverse Events, Serious Adverse Events and Death(From the screening visit until Day 5)