NCT06181630撤回4 期
A Phase IV Postmarketing Study Evaluating Ozanimod Concentrations in the Breast Milk of Lactating Women Receiving Ozanimod Therapeutically
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年11月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Drug daily infant dose
研究概览
简要总结
The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Adult female participant is already planning or currently being treated with ozanimod per the current locally approved prescribing information.
- •Adult female participant has delivered a single normal-term infant (at least 37 weeks gestation).
- •Adult female participant is at least 2 weeks postpartum but not more than 12 months postpartum by Study Visit
- •Infant participant has normal weight for gestational age (above tenth percentile) at birth.
排除标准
- •Adult participant is pregnant, planning to become pregnant, or are of childbearing potential and not using an effective contraceptive method.
- •Adult participant is not breastfeeding or pumping milk.
- •Adult participant has received any live vaccinations within 4 weeks prior to the start of ozanimod treatment.
- •Infant participant was born less than 37 weeks gestation
- •Other protocol-defined criteria apply.
结局指标
主要结局
Drug daily infant dose
时间窗: Predose; Up to 24 hours post dose
Average concentration at steady state (Css-avg) in breast milk
时间窗: Predose; Up to 24 hours post dose
Area under the concentration-time curve over the dosing interval (AUCtau) in breast milk
时间窗: Predose; Up to 24 hours post dose
Drug relative infant dose
时间窗: Predose; Up to 24 hours post dose
次要结局
- Number of participants with adverse events (AEs)(Up to approximately 5 months)
- Plasma trough observed plasma concentration at the end of a dosing interval at steady state (Ctrough)(Predose; Up to 12 hours post dose)
- Number of participants with physical examination abnormalities(Up to approximately 5 months)
- Number of participants with clinical laboratory abnormalities(Up to approximately 5 months)
- Number of participants with vital sign abnormalities(Up to approximately 5 months)
- Time to reach Cmax (Tmax)(Predose; Up to 24 hours post dose)
- Maximum observed concentration in breast milk over the dosing interval (Cmax)(Predose; Up to 24 hours post dose)
- Minimum observed concentration in breast milk over the dosing interval (Cmin)(Predose; Up to 24 hours post dose)
研究者
研究点 (2)
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