NCT00750620已完成1 期
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Effect of Mild, Moderate and Severe Renal Impairment on the Pharmacokinetics of YM178
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
- 33
- 主要终点
- Assessment of pharmacokinetics parameters
研究概览
简要总结
The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good health other than renal impairment
- •body mass index (BMI) between 18 and 40 kg/m2
排除标准
- •subject with renal impairment has not been on stable dose of concomitant medication for at least 2 weeks
- •subject has liver enzyme abnormalities
研究组 & 干预措施
1. Severe renal impairment
Experimental
severe renal impairment
干预措施: YM178 (Drug)
2. Moderate renal impairment
Experimental
moderate renal impairment
干预措施: YM178 (Drug)
3. Mild renal impairment
Experimental
mild renal impairment
干预措施: YM178 (Drug)
4. Normal renal function
Experimental
normal renal function
干预措施: YM178 (Drug)
结局指标
主要结局
Assessment of pharmacokinetics parameters
时间窗: day 1 - day 6
次要结局
- Metabolite analysis(day 1 - day 6)
- Assessment of safety and tolerability(day 1 - day 6)
研究者
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