A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women
Condition(s) studied
Investigational drug(s) / intervention(s)
Etrasimod: Oral 2 milligrams tablet, once a day for 7 days
Study 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
Eligibility
Primary outcome measure(s)
- 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de |
More Pfizer trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07153159 on ClinicalTrials.gov ↗ ← All trials in Belgium