Phase 1 Study of Etrasimod Absorption and Breast Milk Levels in Healthy Breastfeeding Women Aged 18 to 55

What this Trial Is About

Researchers are studying how much etrasimod, a medication, is present in the breast milk of healthy breastfeeding women after taking the drug daily for several days. This phase 1, open-label study involves healthy lactating women aged 18 to 55 who are at least 12 weeks postpartum and not currently pregnant. The purpose is to understand how the drug is absorbed, how it moves through the body, and its levels in breast milk compared to blood, while also monitoring safety. Participants will take a 2 mg oral tablet of etrasimod once daily for 7 days while staying at the testing site. They will temporarily stop breastfeeding their babies for about 21 days, from the evening before the first dose until 14 days after the last dose. During this time, participants must use an alternative feeding plan and regularly pump and express breast milk according to a schedule to maintain lactation until breast milk collection ends. After the last dose, participants will remain at the site for at least 24 hours before going home. Throughout the study, researchers will collect blood and breast milk samples at specific times to measure drug concentration and how it changes over time. Safety will be monitored with physical exams, vital signs, ECGs, and laboratory tests. Follow-up safety calls will occur around 14 days and between 28 to 35 days after the last dose. The entire study process is expected to last about 10 weeks for each participant.

A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women