Open-label, Non-randomised, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Area under the Curve (AUC) of total plasma CHF6001
研究概览
简要总结
The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 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
Mild renal impaired subjects
Administration of a single dose of CH6001 800 µg in mild renal impaired subjects.
干预措施: CH6001 (Drug)
Moderate renal impaired subjects
Administration of a single dose of CH6001 800 µg in moderate renal impaired subjects.
干预措施: CH6001 (Drug)
Severe renal impaired subjects
Administration of a single dose of CH6001 800 µg in severe renal impaired subjects.
干预措施: CH6001 (Drug)
Healthy volunteers
Administration of a single dose of CH6001 800 µg in healthy volunteers.
干预措施: CH6001 (Drug)
结局指标
主要结局
Area under the Curve (AUC) of total plasma CHF6001
时间窗: Over 240 hours after CHF6001 administration
Area under the plasma concentration versus time curve for total plasma CHF6001 after a single-dose of CHF6001
Maximum of Concentration (Cmax) of total plasma CHF6001
时间窗: Over 240 hours after CHF6001 administration
Peak plasma concentration for total plasma CHF6001 after a single-dose of CHF6001
次要结局
- Pharmacokinetic parameter (AUC0-72)(Over 240 hours after administration in blood)
- Pharmacokinetic parameter (AUC0-∞)(Over 240 hours after administration in blood)
- Pharmacokinetic parameter (AUCt)(Over 240 hours after administration in blood)
- Pharmacokinetic parameter ( Cmax)(Over 240 hours after administration in blood)
- Pharmacokinetic parameter (tmax)(Over 240 hours after administration in blood)
- Pharmacokinetic parameter (t1/2)(Over 240 hours after administration in blood)
- Pharmacokinetic parameter (CL/F)(Over 240 hours after administration in blood)
- Pharmacokinetic parameter (AUC0-240)(Over 240 hours after administration in blood)
- Pharmacokinetic parameter (Cmax)(Over 240 hours after administration in blood)