Etrasimod uptake into blood and breast milk of healthy breastfeeding women

A PHASE 1 MULTIPLE-DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ETRASIMOD IN HEALTHY LACTATING WOMEN

This study will test how a daily 2 mg dose of etrasimod shows up in the blood and breast milk of healthy breastfeeding women.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Female
• Sponsor: Pfizer (Industry-sponsored)
• Locations: 1 site (Brussels, Bruxelles-capitale, Région de)
• Trial ID: NCT07153159 on ClinicalTrials.gov

What this trial studies

At least eight healthy lactating women 12 or more weeks postpartum will receive 2 mg of etrasimod once daily for seven days while confined at the Pfizer Clinical Research Unit in Brussels. Participants will not breastfeed their infants during the study window and will regularly pump and express milk according to a schedule to preserve lactation and collect samples. Investigators will collect timed blood and breast milk samples to measure drug concentrations and standard pharmacokinetic parameters such as peak level and time to peak. Safety will be monitored during confinement and with follow-up calls about 14 and 28–35 days after dosing.

Who should consider this trial

Good fit: Healthy lactating women aged 18–55 who are at least 12 weeks postpartum, weigh over 45 kg with BMI 16–35, and who can temporarily stop direct breastfeeding for about 21 days and follow a pumping schedule are eligible.

Not a fit: Women who are pregnant, less than 12 weeks postpartum, unable to pause breastfeeding or comply with inpatient confinement and pumping, or who have medical exclusions are unlikely to receive direct benefit from participating.

Why it matters

Potential benefit: If successful, the results could clarify how much etrasimod transfers into breast milk and help inform breastfeeding guidance for women who may need the medication.

How similar studies have performed: Lactation pharmacokinetic studies using timed blood and milk sampling are a standard method and have been used successfully for other drugs, but etrasimod-specific lactation data are limited.

Eligibility criteria

Inclusion

1. 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).
2. Body mass index (BMI) of 16-35 kg/m2; and a total body weight \>45 kg (99 lb).
3. 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

1. 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).
2. Participants with history or presence of second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block.
3. 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.
4. Recurrent symptomatic bradycardia or recurrent cardiogenic syncope
5. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
6. 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).
7. History or evidence of hepatitis B or hepatitis C viruses. Hepatitis B vaccination is allowed.89.
8. Participants with any of the acute or chronic infections or infection history

Where this trial is running

Brussels, Bruxelles-capitale, Région de

• Pfizer Clinical Research Unit - Brussels — Brussels, Bruxelles-capitale, Région de, Belgium (Recruiting)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions Healthy Participant; Breast feeding women