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NCT Number: NCT07153159

A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women

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

Recruiting

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etrasimod

Drug

Oral 2 milligrams tablet, once a day for 7 days

Primary outcomes

  1. Area under the etrasimod concentration-time curve in breast milk

    Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.

  2. Maximum observed concentration of etrasimod in breast milk

    Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.

  3. Amount of etrasimod excreted in breast milk

    Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.

  4. Percent of etrasimod dose excreted in breast milk

    Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.

  5. Breast milk clearance of etrasimod

    Time frame: Baseline through Day 8

    Baseline (Day -1), Day 1, Day 7 and Day 8.

  6. Time to maximum observed concentration of etrasimod

    Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Breast milk to plasma ratio for area under the concentration-time curve

    Time frame: Baseline (Day -1), Day 1, Day 7 and Day 8.

  5. percentage of treatment emergent adverse events in participants

    Time frame: Baseline through Day 35

  6. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

    Time frame: Baseline through Day 8

  7. Number of Participants With Clinically Significant Change From Baseline in vital signs (blood pressure and heart rate)

    Time frame: Baseline through Day 8

  8. Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters

    Time frame: Baseline through Day 8

  9. Body weight normalized infant dose in μg/kg/day

    Time frame: Baseline through Day 8

  10. Body weight normalized maternal dose in μg/kg/day

    Time frame: Baseline through Day 8

  11. Infant dose expressed as % of body weight normalized maternal dose

    Time frame: Baseline through Day 8

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Apr 7, 2026

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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