NCT05632393已完成1 期
A Prospective, Open-label, Single-dose Phase 1 Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Milk pharmacokinetic endpoints: Amount of daridorexant excreted (mg)
研究概览
简要总结
A study to measure daridorexant in breast milk of healthy lactating women
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- •Healthy lactating female subject aged at least 18 years at Screening.
- •Female subject who has delivered a term infant (≥ 37 weeks' gestation) and who is breastfeeding her infant (and/or pumping) for at least 2 weeks postpartum at Screening; lactation must be well-established to maintain an adequate milk supply with regular breastfeeding (and/or pumping, e.g., 3 to 4 times per day and not providing more than 1 supplemental bottle of formula per day and the infant has not started eating solids). Subjects planning on weaning their infants after enrollment who meet the afore mentioned requirements will be considered for enrollment in the study.
- •Agreement to refrain from breastfeeding any infant with her own milk from Day -1 up to 72 h after study treatment administration.
- •Ability of subject's infant to feed from a bottle or no anticipated compromise of subject's infant's nutrition with time period of refraining from breastfeeding planned during the study.
- •Agreement to collect breast milk from pre-dose (directly prior to study treatment administration) to Day 4 (72 h after study treatment administration) using an electric pump provided by the study site.
- •Must agree to use an acceptable effective method of contraception consistently and correctly (e.g., oral progestin-only contraceptive; implants; intra uterine devices; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide) from Screening up to at least 72 h after study treatment administration, be sexually inactive, or be in same-sex relationship.
排除标准
- •Known hypersensitivity to daridorexant or treatments of the same class, or any of its excipients.
- •History of narcolepsy.
- •Mastitis or other condition that prevents the collection of breast milk from one or both breasts at Screening or on Day -
- •History of breast implants, breast augmentation, or breast reduction surgery which prevents the collection of breast milk.
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
研究组 & 干预措施
Daridorexant 50 mg
Experimental
Daridorexant 50 mg will be administered once in the morning of Day 1.
干预措施: Daridorexant (Drug)
结局指标
主要结局
Milk pharmacokinetic endpoints: Amount of daridorexant excreted (mg)
时间窗: 0 to 72 hours after study treatment administration (Total duration: up to 4 days)
Cumulative amount excreted in breast milk over the collection time
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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