A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breast
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. Durin
| Condition(s) | Healthy Participant |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 w |
| Who can participate | Inclusion 1. Healthy (as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs) lactating women who are actively breastfeeding or expressing breast milk, who are at least 12 weeks post partum and not currently pregnant (must have a negative pregnancy test), and must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD). 2. Body mass index (BMI) of 16-35 kg/m2; and a total body weight \>45 kg (99 lb). 3. Participants must be willing to temporarily discontinue breastfeeding their infants for a total of 21 days, ie, from the evening of the day before Day 1 through to 14 days after the last dose (approximately 8 AM the morning of Day 21). Participants must be willing to regularl |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Pfizer |
| Locations | Brussels, Bruxelles-capitale, Région de, Belgium |
| Start date | 2025-08-07 |
| NCT ID | NCT07153159 |
| Official listing | https://clinicaltrials.gov/study/NCT07153159 |