Pharmacokinetics, Safety and Tolerability of BI 201335 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase I Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- AUC0-∞
研究概览
简要总结
The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.
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 75 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
BI 201335 relevant treatment dose (A)
Capsule for oral administration
干预措施: BI 201335 (Drug)
BI 201335 relevant treatment dose (B)
Capsule for oral administration
干预措施: BI 201335 (Drug)
结局指标
主要结局
AUC0-∞
时间窗: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration
area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity. In this endpoint, the data of AUC0-∞ show inter-individual variabilities.
Cmax
时间窗: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration
maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.
次要结局
- Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG(from drug administration up to 2 weeks)
- Number of Participants With Drug Related Adverse Events(drug administration until end-of-study examination (7 to 14 days after drug administration))