A Phase 4 Open-label, Non-randomized Study Evaluating the Pharmacokinetics and Safety of TRULANCE® (Plecanatide) in Breast Milk of Lactating Women Treated With TRULANCE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Aτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk
研究概览
简要总结
This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE
详细描述
This is an open-label study in lactating women who have been prescribed TRULANCE® by their healthcare provider. The study will assess the pharmacokinetics of plecanatide and its active metabolite in breast milk of lactating women treated therapeutically with TRULANCE. Subjects will be screened prior to admission for Baseline assessments. Following final qualifications, the morning dose of TRULANCE will be administered under supervision from study personnel and serial samples of breast milk will be collected via breast pump.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Females ≥ 18 years of age
- •Has been breastfeeding or actively pumping for at least 4 weeks
- •Has been prescribed TRULANCE by a healthcare provider and has taken it for a minimum of 14 consecutive days before anticipated Baseline Visit
- •Has the ability to understand and communicate the requirements of the study and is willing to continue breastfeeding or regular pumping in order to maintain milk supply for the duration of the study
- •Weaning must not be underway
排除标准
- •Has clinically significant medical or psychiatric condition (as determined by the Medical Monitor) other than the medical condition being treated with TRULANCE
- •Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
- •Has participated in an investigational drug study within the 90 days prior to CRU admission
结局指标
主要结局
Aτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk
时间窗: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Amount (of unchanged drug) excreted into the milk during a dosing interval at steady state a dosing interval (τ) at steady state
Cavg,ss of TRULANCE (plecanatide) and its active metabolite in breast milk
时间窗: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Average concentration of TRULANCE (plecanatide) in breast milk at steady state
Cmax,ss of TRULANCE (plecanatid) and its active metabolite in breast milk
时间窗: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Maximum observed concentration of TRULANCE (plecanatide) in breast milk during a dosing interval at steady state
AUCτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk
时间窗: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Area under the concentration-time curve during a dosing interval at steady state interval at steady state
次要结局
未报告次要终点