Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
Location status: Recruiting
NCT Number: NCT07153159
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
Interested in participating?
Request Info18 year–55 year
Female
Interventional
Phase 1
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion
Exclusion
Oral 2 milligrams tablet, once a day for 7 days
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Time frame: Baseline through Day 8
Baseline (Day -1), Day 1, Day 7 and Day 8.
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Time frame: Day 1 hour 0, Day 7 hour 0, 1, 2, 4, 6, 8 and 12, Day 8 hour 24
Time frame: Day 1 hour 0, Day 7 hour 0, 1, 2, 4, 6, 8 and 12, Day 8 hour 24
Time frame: Day 1 hour 0, Day 7 hour 0, 1, 2, 4, 6, 8 and 12, Day 8 hour 24
Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.
Time frame: Baseline through Day 35
Time frame: Baseline through Day 8
Time frame: Baseline through Day 8
Time frame: Baseline through Day 8
Time frame: Baseline through Day 8
Time frame: Baseline through Day 8
Time frame: Baseline through Day 8
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
A PHASE 1 MULTIPLE-DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ETRASIMOD IN HEALTHY LACTATING WOMEN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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