Drugs in Breast Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- concentrations of target drugs in breast milk
研究概览
简要总结
There is a significant lack of information on drug secretion into milk and infant exposure. As a first step to address this issue, the investigators examine milk concentrations of selected drugs prescribed to breastfeeding women, which lack milk excretion data. Milk data will be analyzed using population pharmacokinetic approaches, when possible, and acquired data of drug concentration profiles in milk will be combined with infant physiologically-based pharmacokinetic (PBPK) models to predict infant exposure levels.
详细描述
In this study the investigators measure drug concentrations in breast milk (and optional blood) samples collected through sparse and flexible sampling strategy mitigating intense approaches of conventional PK study. Whenever possible, population PK method is used to characterize milk concentration profiles of the selected drugs. The obtained data is further processed through a PBPK model of infant to predict infant drug exposure levels.
The study also includes an optional pharmacogenetic part. This will allow the investigators to understand how variations in genetic composition plays role in breaking down drugs and how it affects the drug transfer into breast milk.
This study is conducted at three sites: Hospital for Sick Children (leading site), CHU Sainte Justine Hospital, Montreal (Study Lab: for drug measurement), and University of Waterloo (Modelling Core: to create computer model).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Breastfeeding women
Either of the following drugs at steady state (Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe).
干预措施: either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe (Drug)
结局指标
主要结局
concentrations of target drugs in breast milk
时间窗: an average of 1 year
using assays of drug concentrations validated in human milk as a matrix
次要结局
未报告次要终点
研究者
Shinya Ito
Senior Scientist
The Hospital for Sick Children