A PHASE 1 MULTIPLE-DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ETRASIMOD IN HEALTHY LACTATING WOMEN
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Area under the etrasimod concentration-time curve in breast milk
研究概览
简要总结
This study aims to figure out how much etrasimod, a medication, ends up in breast milk after taking it for several days. To do this, the researchers will work with at least 8 healthy women who are breastfeeding. These women will take a 2 mg dose of etrasimod every day for 7 days while staying at the testing site. During the study, they won't be allowed to breastfeed their babies to keep the babies safe. Instead, they need to have another plan for feeding their babies during this time. The study will look at how the medication is absorbed and how it moves through the body, checking things like the highest level in the blood and how long it takes to reach that level. The researchers will also see how much of the drug is in the breast milk compared to the blood and whether it's safe for the women to take. After the last dose, the women will stay at the site for at least another 24 hours before going home, and follow-up safety calls will be made about 14 and 28 to 35 days later. The whole process from start to finish will take about 10 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 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 breast feeding volunteers
干预措施: Etrasimod (Drug)
结局指标
主要结局
Area under the etrasimod concentration-time curve in breast milk
时间窗: Baseline (Day -1), Day 1, Day 7 and Day 8.
Maximum observed concentration of etrasimod in breast milk
时间窗: Baseline (Day -1), Day 1, Day 7 and Day 8.
Amount of etrasimod excreted in breast milk
时间窗: Baseline (Day -1), Day 1, Day 7 and Day 8.
Percent of etrasimod dose excreted in breast milk
时间窗: Baseline (Day -1), Day 1, Day 7 and Day 8.
Breast milk clearance of etrasimod
时间窗: Baseline through Day 8
Baseline (Day -1), Day 1, Day 7 and Day 8.
Time to maximum observed concentration of etrasimod
时间窗: Baseline (Day -1), Day 1, Day 7 and Day 8.
次要结局
- Breast milk to plasma ratio for area under the concentration-time curve(Baseline (Day -1), Day 1, Day 7 and Day 8.)
- Area under the etrasimod concentration-time curve in plasma(Day 1 hour 0, Day 7 hour 0, 1, 2, 4, 6, 8 and 12, Day 8 hour 24)
- Maximum observed concentration of etrasimod in plasma(Day 1 hour 0, Day 7 hour 0, 1, 2, 4, 6, 8 and 12, Day 8 hour 24)
- Time to maximum observed concentration of etrasimod in plasma(Day 1 hour 0, Day 7 hour 0, 1, 2, 4, 6, 8 and 12, Day 8 hour 24)
- percentage of treatment emergent adverse events in participants(Baseline through Day 35)
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities(Baseline through Day 8)
- Body weight normalized maternal dose in μg/kg/day(Baseline through Day 8)
- Infant dose expressed as % of body weight normalized maternal dose(Baseline through Day 8)
- Number of Participants With Clinically Significant Change From Baseline in vital signs (blood pressure and heart rate)(Baseline through Day 8)
- Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters(Baseline through Day 8)
- Body weight normalized infant dose in μg/kg/day(Baseline through Day 8)