NCT01120314已完成1 期
An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 µg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))
研究概览
简要总结
Primary Objective:
- To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban.
Secondary Objective:
- To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.
详细描述
The study period for one subject is broken down as follows:
- 2 to 28 days of screening,
- 1 day of treatment,
- 8 to 11 days of follow-up after start of infusion.
There are 5 days in the unit starting the day before the start of infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Severe renal impairment population
Experimental
干预措施: OTAMIXABAN (XRP0673) (Drug)
Moderate renal impairment population
Experimental
干预措施: OTAMIXABAN (XRP0673) (Drug)
Mild renal impairment population
Experimental
干预措施: OTAMIXABAN (XRP0673) (Drug)
Healthy population
Experimental
Healthy matched subjects
干预措施: OTAMIXABAN (XRP0673) (Drug)
结局指标
主要结局
Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))
时间窗: 4 days
次要结局
- Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR))(4 days)
研究者
研究点 (4)
Loading locations...
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