Status:
RECRUITING
A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women
Lead Sponsor:
Pfizer
Conditions:
Healthy Participant
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
Brief 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 bre...
Eligibility Criteria
Inclusion
- Inclusion
- 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).
- Body mass index (BMI) of 16-35 kg/m2; and a total body weight \>45 kg (99 lb).
- 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 regularly pump breasts throughout the study and express breast milk according to a schedule designed to maintain lactation until the completion of breast milk collection
- Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary (such as moderate or severe chronic pulmonary disorders like asthma or chronic obstructive pulmonary disease \[COPD\]), gastrointestinal, cardiovascular, hepatic, neurological/psychiatric, anaphylactic, ophthalmologic disorders (such as macular edema, uveitis, retinopathy), or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Participants with history or presence of second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block.
- Resting HR \<50 bpm at Screening or pre-randomization on Day 1. Measurement can be repeated up to 3 times to confirm the finding. Mean values will be used if repeated.
- Recurrent symptomatic bradycardia or recurrent cardiogenic syncope
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV), or a first degree relative with a hereditary immunodeficiency, and history of organ transplant (except corneal transplant).
- History or evidence of hepatitis B or hepatitis C viruses. Hepatitis B vaccination is allowed.89.
- Participants with any of the acute or chronic infections or infection history
Exclusion
Key Trial Info
Start Date :
August 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 12 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT07153159
Start Date
August 7 2025
End Date
October 12 2026
Last Update
September 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium, B-1070