Demographics in Pharmacokinetics of Anti-epileptic Drugs in Obese Children - Oxcarbazepine

Participant Demographic Information
Study Description
This was a multi-center, prospective, open-label, pharmacokinetic (PK) and safety study of anti-epileptic drugs in obese children age 2 to less than 18 years of age who received drugs per standard of care (SOC), as prescribed by a treating clinician. Participants were enrolled under multiple drugs of interest, including oxcarbazepine. Simulations from the PK models revealed that the currently recommended dosing regimen of oxcarbazepine produced equivalent steady state exposure of its active metabolite between children with and without obesity from 2 to 20 years of age. Therefore, the current population PK analysis confirms the applicability of the currently recommended dosing regimen of oxcarbazepine in children with obesity. No adverse events were reported in the oxcarbazepine participants, and no safety concerns were identified in this SOC study. Participants who received oxcarbazepine and were included in the safety population.

受试者人口统计学信息
研究概况
本研究为一项多中心、前瞻性、开放标签的药代动力学（pharmacokinetic，PK）与安全性研究，纳入对象为2岁至18岁以下的肥胖儿童，所有受试儿童均按照临床医师开具的标准治疗方案（standard of care，SOC）接受抗癫痫药物治疗。本研究纳入了多种目标治疗药物的受试者队列，其中包含奥卡西平（oxcarbazepine）。
药代动力学模型模拟结果显示，在2至20岁的儿童群体中，当前推荐的奥卡西平给药方案所产生的活性代谢物稳态暴露量，在肥胖与非肥胖儿童间无统计学差异。因此，本次群体药代动力学分析证实，当前推荐的奥卡西平给药方案可安全有效地应用于肥胖儿童群体。
奥卡西平受试队列未报告任何不良事件，本标准治疗方案研究亦未发现任何安全性隐患。纳入本次安全性分析人群的受试者均为接受奥卡西平治疗的受试者。