NCT01707394已完成1 期
Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder
Bristol-Myers Squibb21 个研究点 分布在 3 个国家目标入组 49 人开始时间: 2013年1月10日最近更新:
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
- 入组人数
- 49
- 试验地点
- 21
- 主要终点
- Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban
研究概览
简要总结
CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis
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
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder
- •Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to <18 years of age
- •Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age
- •Neonates: defined as newly born (within 4 weeks)
- •Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system
排除标准
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug
- •Active bleeding or high risk of bleeding
- •Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube [NG tube] or gastronomy tube [G-tube])
研究组 & 干预措施
Group 3: Apixaban (low dose)
Experimental
干预措施: Apixaban (Drug)
Group 4: Apixaban (low dose)
Experimental
干预措施: Apixaban (Drug)
Group 1: Apixaban (low dose)
Experimental
干预措施: Apixaban (Drug)
Group 2A: Apixaban (low dose)
Experimental
干预措施: Apixaban (Drug)
Group 2B: Apixaban (low dose)
Experimental
干预措施: Apixaban (Drug)
Group 5: Apixaban (low dose)
Experimental
干预措施: Apixaban (Drug)
Group 2A (higher dose): Apixaban (low dose)
Experimental
干预措施: Apixaban (Drug)
结局指标
主要结局
Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban
时间窗: Up to 26 hours, post dose (from Day 1 to Day 2)
Maximum estimated plasma concentration (Cmax) of Apixaban
时间窗: Up to 26 hours, post dose (from Day 1 to Day 2)
Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban
时间窗: Up to 26 hours, post dose (from Day 1 to Day 2)
次要结局
- Number of participants with Adverse Events (AEs)(Up to 30 Days after last dosing)
- Change from baseline in Vital Signs of heart rate(Up to 30 Days after last dosing)
- Change from baseline in Clinical Laboratory Tests of blood serum(Up to 30 Days after last dosing)
- Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment(Up to 30 Days after last dosing)
- Change from baseline in International Normalized Ratio (INR) clotting activity during treatment(Up to 30 Days after last dosing)
- Change from baseline in Clinical Laboratory Tests of urine(Up to 30 Days after last dosing)
- Change from baseline in Vital Signs of blood pressure(Up to 30 Days after last dosing)
- Number of participants with abnormalities in Physical Examinations(Up to 30 Days after last dosing)
- Number of participants with Serious Adverse Events (SAEs)(Up to 30 Days after last dosing)
- Change from baseline in Vital Signs of body temperature(Up to 30 Days after last dosing)
- Change from baseline in Clinical Laboratory Tests of blood(Up to 30 Days after last dosing)
- Change from baseline in Prothrombin Time (PT) clotting activity during treatment(Up to 30 Days after last dosing)
- Pharmacodynamics will be analyzed using anti-Factor Xa activity(Up to 26 hours, post dose (from Day 1 to Day 2))
- Change from baseline in Vital Signs of respiratory rate(Up to 30 Days after last dosing)
研究者
研究点 (21)
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