A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women
- Registration Number
- NCT07153159
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 8
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description healthy breast feeding volunteers Etrasimod -
- Primary Outcome Measures
Name Time Method Area under the etrasimod concentration-time curve in breast milk Baseline (Day -1), Day 1, Day 7 and Day 8. Maximum observed concentration of etrasimod in breast milk Baseline (Day -1), Day 1, Day 7 and Day 8. Amount of etrasimod excreted in breast milk Baseline (Day -1), Day 1, Day 7 and Day 8. Percent of etrasimod dose excreted in breast milk Baseline (Day -1), Day 1, Day 7 and Day 8. Breast milk clearance of etrasimod Baseline through Day 8 Baseline (Day -1), Day 1, Day 7 and Day 8.
Time to maximum observed concentration of etrasimod Baseline (Day -1), Day 1, Day 7 and Day 8.
- Secondary Outcome Measures
Name Time Method 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 Breast milk to plasma ratio for area under the concentration-time curve Baseline (Day -1), Day 1, Day 7 and Day 8. 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
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit - Brussels
🇧🇪Brussels, Bruxelles-capitale, Région de, Belgium
Pfizer Clinical Research Unit - Brussels🇧🇪Brussels, Bruxelles-capitale, Région de, Belgium