NCT02220348已完成1 期
An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically
Forest Laboratories2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2014年7月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
研究概览
简要总结
The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be a lactating female who has been actively breastfeeding or pumping for at least 4 weeks
- •Be already taking linaclotide therapeutically for Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)
- •Weaning must not be underway
- •Be willing to breastfeed or pump regularly during the study to maintain milk supply and discontinue breastfeeding for the 24-hour period of breast milk collection
排除标准
- •Clinically significant disease state in any body system, except for the indication being treated with linaclotide
- •Any structural abnormality of the gastrointestinal (GI) tract, or a disease or condition that can affect GI motility
- •Participation in any other clinical investigation using an experimental drug within 90 days
研究组 & 干预措施
linaclotide
Experimental
Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration
干预措施: linaclotide (Drug)
结局指标
主要结局
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
时间窗: From Baseline (Day 1) to Day 4
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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