Drug of Interest Completion in Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Ondansetron

Drug of Interest Completion data
Study Description
Aim: Characterize the pharmacokinetics (PK) of ondansetron administered to children per standard of care as prescribed by their treating caregiver. Methods: The PK and safety analyses in this report include ondansetron data from NICHD-2011-POP01 (“Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care”), a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who receive drugs per standard of care, as prescribed by a treating caregiver. The NICHD-2011-POP01 study enrolls participants under multiple drugs of interest (DOI) including ondansetron, and continues to enroll participants under other DOIs.
Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ondansetron were reported. 109 participants enrolled under ondansetron, 93 (85.3%) were eligible for the PK analysis. One participant enrolled in two 90-day enrollment segments.

目标药物研究完成数据集

研究描述

研究目的：旨在明确由主治医护人员按照临床诊疗规范开具给药方案的儿童受试者使用昂丹司琼的药代动力学（pharmacokinetics, PK）特征。

研究方法：本报告中的药代动力学与安全性分析数据来源于NICHD-2011-POP01研究（研究标题：《按临床诊疗规范给药的儿童未充分研究药物的药代动力学》），该研究为一项多中心前瞻性机会性药代动力学研究，纳入对象为年龄不足21岁、且按照主治医护人员开具的临床诊疗规范接受药物治疗的未充分研究药物受试者。本NICHD-2011-POP01研究纳入了多种目标药物（Drug of Interest, DOI）项下的受试者，其中包含昂丹司琼组，目前仍在招募其他目标药物项下的受试者。

研究结果：未报告与研究流程相关的不良事件（Adverse Events, AEs）及严重不良事件（Serious Adverse Events, SAEs）。未报告与昂丹司琼相关的严重、意外、疑似不良反应。昂丹司琼组共纳入109名受试者，其中93名（85.3%）符合药代动力学分析的入组条件。有1名受试者参与了两段90天的入组周期。