NCT03189615已完成1 期
Interventional, Open-label, Three-group, Single-dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Hepatic Impairment (Mild or Moderate) and in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
研究概览
简要总结
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of a single oral dose of Lu AF35700
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with hepatic impairment disease stage Child-Pugh's Criteria A (mild) or Child-Pugh's Criteria B (moderate) and healthy subjects with normal hepatic function
- •Subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive)
排除标准
- •Subjects previously been dosed with Lu AF35700
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Patients with mild hepatic impairment (Group1)
Experimental
干预措施: Lu AF35700 (Drug)
Patients with moderate hepatic impairment (Group 2)
Experimental
干预措施: Lu AF35700 (Drug)
Healthy subjects (Group 3)
Experimental
干预措施: Lu AF35700 (Drug)
结局指标
主要结局
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
时间窗: Predose to day 57 postdose
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Maximum observed plasma concentration (Cmax) of Lu AF35700
时间窗: Predose to day 57 postdose
Maximum observed plasma concentration (Cmax) of Lu AF35700
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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