NCT01195727终止1 期
Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
Bristol-Myers Squibb5 个研究点 分布在 2 个国家目标入组 13 人开始时间: 2011年7月26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
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Pharmacokinetic (PK): Model-derived population & individual PK parameters (e.g., CL/F, Vc/F, KA) used to estimate steady state Cmax & AUC(TAU), Cmin & Tmax in each subject. Population PK model will be developed using plasma concentration vs time data
研究概览
简要总结
CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects with a central venous catheter.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with chronic stable disease with any type of functioning CVC in the upper or lower venous system (e.g., jugular, subclavian; femoral vein) that is anticipated to remain in the subject for the treatment portion of the study.
- •> 12 to <18 years of age
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
研究组 & 干预措施
Group 5B - Apixaban (High Dose)
Experimental
Group 5: 12 years to <18 years;
1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days
干预措施: Apixaban (Drug)
Group 5A - Apixaban (Low Dose)
Experimental
Group 5: 12 years to <18 years;
0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days
干预措施: Apixaban (Drug)
结局指标
主要结局
Pharmacokinetic (PK): Model-derived population & individual PK parameters (e.g., CL/F, Vc/F, KA) used to estimate steady state Cmax & AUC(TAU), Cmin & Tmax in each subject. Population PK model will be developed using plasma concentration vs time data
时间窗: Days 1, 2, Day 5, 6 or 7 and Day 11
次要结局
- Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis(Days 1, 2, Day 5, 6 or 7)
研究者
研究点 (5)
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