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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Oral 2 milligrams tablet, once a day for 7 days
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium
RECRUITINGArea under the etrasimod concentration-time curve in breast milk
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Maximum observed concentration of etrasimod in breast milk
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Amount of etrasimod excreted in breast milk
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Percent of etrasimod dose excreted in breast milk
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Breast milk clearance of etrasimod
Baseline (Day -1), Day 1, Day 7 and Day 8.
Time frame: Baseline through Day 8
Time to maximum observed concentration of etrasimod
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Area under the etrasimod concentration-time curve in plasma
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
percentage of treatment emergent adverse events in participants
Time frame: Baseline through Day 35
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: Baseline through Day 8
Number of Participants With Clinically Significant Change From Baseline in vital signs (blood pressure and heart rate)
Time frame: Baseline through Day 8
Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters
Time frame: Baseline through Day 8
Body weight normalized infant dose in μg/kg/day
Time frame: Baseline through Day 8
Body weight normalized maternal dose in μg/kg/day
Time frame: Baseline through Day 8
Infant dose expressed as % of body weight normalized maternal dose
Time frame: Baseline through Day 8
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