Postpartum Activity and Expression of BCRP and OCT1 Drug Transporters in the Mammary Gland
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mammary epithelial cell expression of BCRP
研究概览
简要总结
This is a prospective, non-randomized, phase I study design evaluating the in vivo activities and expression of OCT1 and BCRP in mammary gland of lactating women at three time points postpartum.
详细描述
Each woman will receive a single oral dose of cimetidine 200 mg on each of 3 study days (3-5 weeks, 3-4 months, and 6-8 months postpartum) followed by serial collection of blood, urine and breast milk samples over 12-hours. Cimetidine concentrations will be assay using a validated LC/MS/MS assay. Subjects will be genotyped for OCT1 and BCRP. Mammary epithelial cells will be isolated from breast milk and transporter expression will be quantified. Each woman will serve as her own control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 14 Days 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Healthy Lactating Women
Healthy Lactating Women will be studied on 3 study days and serve as their own control.
干预措施: Cimetidine 200 MG (Drug)
结局指标
主要结局
Mammary epithelial cell expression of BCRP
时间窗: 3-5 weeks, 3-4 months and 6-8 months postpartum
BCRP protein expression in MECs at three postpartum stages
Mammary clearance of cimetidine
时间窗: 3-5 weeks, 3-4 months and 6-8 months postpartum
Cimetidine excretion into breast milk at three postpartum stages
Mammary epithelial cell expression of OCT1
时间窗: 3-5 weeks, 3-4 months and 6-8 months postpartum
OCT1 protein expression in MECs at three postpartum stages
次要结局
- Cimetidine relative infant dose and infant concentration(3-5 weeks, 3-4 months and 6-8 months postpartum)
- Maternal cimetidine PK(3-5 weeks, 3-4 months and 6-8 months postpartum)
- Relationship between BCRP expression and activity(3-5 weeks, 3-4 months and 6-8 months postpartum)
- Relationship between OCT1 expression and activity(3-5 weeks, 3-4 months and 6-8 months postpartum)
研究者
Mary Hebert
Professor: Pharmacy; Adjunct Professor, Obstetrics & Gynecology
University of Washington