NCT01126086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 and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z
研究概览
简要总结
Primary Objective:
- To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban.
Secondary Objective:
- To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.
详细描述
The duration of each part of the study for one subject was 28 days of screening, 1 day of treatment, with 5 days in the unit (Day -1 to Day 4) and a 8 to 11 days of follow-up after 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
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mild impairment
Experimental
Patients with mild hepatic impairment
干预措施: otamixaban XRP0673 (Drug)
Moderate impairment
Experimental
Patients with moderate impairment
干预措施: otamixaban XRP0673 (Drug)
Healthy subjects
Experimental
Matched healthy subjects
干预措施: otamixaban XRP0673 (Drug)
结局指标
主要结局
PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z
时间窗: Day 1 to Day 4
Pharmacodynamic based on coagulation parameters, activated partial prothrombin time (aPTT), prothrombin time (PT), and international normalized ratio (INR)
时间窗: Screening (-28 days) up to 4 days after treatment
次要结局
- Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG(Screening (-28 days) up 8 to 11 days after treament)
研究者
研究点 (3)
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