在患有血栓栓塞/心血管事件风险的人群中,阿桑德西安的种群药动力学
Ashraf Yassen1, Friederike Kanefendt2, Jochen Zisowsky3
1Bayer AG, Model-Informed Drug Development, Wuppertal, Germany.
CPT: pharmacometrics & systems pharmacology
|November 12, 2025
概括
作为一个undexian.
科学领域:
- 药理学和药物开发领域
- 临床药理学 临床药理学
- 心血管研究研究心血管研究
背景情况:
- 阿桑德西安是一种研究中的XI因子抑制剂,用于二次中风预防.
- 它目前正在OCEANIC-STROKE第三阶段研究中进行评估.
- 了解其药理动力学特征对于优化其使用至关重要.
研究的目的:
- 开发一个群体药理动力学 (popPK) 模型,用于asundexian.
- 在各种研究和种群中描述阿桑德西安的药理动力学特性.
- 为了确定影响asundexian药理动学的因素.
主要方法:
- 一个人群的药理动力学模型是使用来自第I期和第II期研究的2914名参与者的血度数据来开发的.
- 评估了剂量比例性,清除 (CL/F) 和分布体积 (VC/F).
- 进行了共变量分析,以确定影响PK和PK的因素.
主要成果:
- 阿桑德西安在10-100毫克每日一次剂量范围内表现出剂量比例的药理动力学.
- 估计了关键的药理动力学参数:CL/F为2.25 L/h,VC/F为35.3 L.
- 体重,年龄,性别,CYP3A4抑制剂和功能是显著的共同变量,但不需要调整剂量.
结论:
- popPK模型充分描述了asundexian的药理动力学.
- 阿森德西安PK在健康个体和有血栓塞栓事件风险的人群中是可比的.
- 没有发现临床相关的共变量,需要在特殊人群中进行剂量调整,以预防二次中风.
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