Actively Recruiting
A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women
Led by Pfizer · Updated on 2026-04-07
8
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy lactating women actively breastfeeding or expressing breast milk
- At least 12 weeks postpartum
- Not currently pregnant with a negative pregnancy test
- Between 18 and 55 years of age at consent
- Body mass index (BMI) between 16 and 35 kg/m2
- Total body weight over 45 kg (99 lb)
- Willing to temporarily stop breastfeeding for 21 days from the evening before Day 1 through 14 days after last dose
- Willing to regularly pump and express breast milk according to study schedule
You will not qualify if you...
- History or evidence of significant blood, kidney, hormone, lung, digestive, heart, liver, nervous system, psychiatric, allergic, or eye disorders
- History or presence of second- or third-degree atrioventricular block, sick sinus syndrome, or sinoatrial block
- Resting heart rate below 50 beats per minute at screening or Day 1
- Recurrent symptomatic slow heart rate or fainting due to heart issues
- Conditions affecting drug absorption such as gastrectomy or cholecystectomy
- Known immune deficiency or positive HIV test, or history of organ transplant (except corneal)
- History or evidence of hepatitis B or C viruses (vaccination allowed)
- Any acute or chronic infections or infection history
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium, B-1070
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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