EUCTR2012-000983-27-DE进行中（未招募）不适用
A single-dose, open-label parallel-group study to assess the pharmacokinetics of LCZ696 in subjects with hepatic impairment compared to matched healthy subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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/m2.
- •- Hepatic impairment subjects:
- •Mild or moderate hepatic impairment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
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.
研究者
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