在家自行收集药理动力学数据:一期开放标签可行性试验的设计和结果
Arash Raoufinia1, Susan E Shoaf1, Brian Rothman1
1Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
Clinical pharmacology in drug development
|December 4, 2024
概括
这项药理动力学研究发现,参与者在家中准确地收集了自己的血液微样,生命体征和心电图. 这支持了临床试验中远程数据收集的可行性.
科学领域:
- 临床药理学 临床药理学
- 药理动力学 药理动力学
- 药物开发 药物开发
背景情况:
- 药理动力学 (PK) 研究存在重大技术挑战.
- 准确的数据收集对于可靠的PK评估至关重要.
- 分散的试验方法为提高效率和参与者方便提供了潜在的解决方案.
研究的目的:
- 为了评估参与者收集的药理动力学样本和工作人员收集的药理动力学样本和安全数据的时间准确性.
- 评估健康成年人中纳法丁的安全性和耐受性.
- 确定一期临床试验中远程数据收集的可行性.
主要方法:
- 进行了第一阶段,开放标签,固定的序列药理动力学试验.
- 健康的成年人接受了百纳法丁 (100毫克持续释放) 在四次访问.
- 数据收集方法包括工作人员采集的静脉样本,参与者采集的血液微样本,心电图和生命体征,随着越来越多的远程参与.
主要成果:
- 至少75%的参与者在预定时间的10分钟内成功收集了血液微样.
- 无论采集方法如何,心电图和生命体征的时间差异都是最小的.
- 没有任何不良事件被归因于Centanafadine治疗,表明良好的耐受性.
结论:
- 参与者收集的药理动力学样本,心电图和生命体征显示出高时间精度.
- 在临床试验中,参与者的远程数据收集是可行的,也是准确的.
- 在这个健康的成年人群中,Centanafadine是安全的,并且能很好地耐受.
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