Supplemental Specimen Attributes in Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Doxycycline

Supplemental Specimen Attributes
Study Description
Aim: Characterize the PK of doxycycline administered to children per standard of care as prescribed by their treating caregiver.

Methods: The PK and safety analyses was conducted for doxycycline data from NICHD-2011-POP01, 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 doxycycline, and is actively enrolling participants.

Results: A one-compartment model offered the best fit to characterize doxycycline PK data based on model selection criteria. No AEs or SAEs related to study procedures were reported. Children less than 21 years of age who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver who are able to consent/assent and are not pregnant

补充样本属性
研究概况
研究目的：按照治疗医师开具的标准治疗方案，对给予儿童受试者的多西环素的药代动力学（Pharmacokinetics, PK）特征进行表征。
研究方法：针对来自NICHD-2011-POP01研究的多西环素数据开展药代动力学与安全性分析。该研究为一项多中心、前瞻性机会性药代动力学研究，针对年龄小于21岁、按照治疗医师开具的标准治疗方案接受用药的儿童群体，对其中尚未被充分研究的药物开展研究。NICHD-2011-POP01研究目前正为多种目标研究药物（Drug of Interest, DOI）招募受试者，多西环素即为其中之一，且招募工作仍在持续进行中。
研究结果：基于模型选择标准，一室模型可最佳拟合多西环素的药代动力学数据。未报告与研究流程相关的不良反应（Adverse Event, AE）及严重不良反应（Severe Adverse Event, SAE）。本研究的适用人群为：年龄小于21岁、按照治疗医师开具的标准治疗方案接受尚未被充分研究的目标研究药物、能够签署知情同意/未成年同意书且未妊娠的儿童受试者。