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

Trial details

Who runs it

Pfizer Inc.

Trial code

EU 2025-520930-44-00

Record updated

2026. március 2.

Original description

To evaluate the amount of etrasimod secreted in human breast milk following multiple oral doses of etrasimod 2 mg at steady state in lactating women.Read full original descriptionShow less

C5041053 - A PHASE 1 MULTIPLE-DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ETRASIMOD IN HEALTHY LACTATING WOMEN

To evaluate the amount of etrasimod secreted in human breast milk following multiple oral doses of etrasimod 2 mg at steady state in lactating women.

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: A positive urine drug test. A single repeat for positive drug screen may be allowed; 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); History of any lymphoproliferative disorder such as Epstein-Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease. Known present or a history of malignancy other than a successfully treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ; Evidence of active Mycobacterium tuberculosis (TB) infection in the past. Adequately treated latent TB will be permitted; Participants who in the last 6 months experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or New York Heart Association (NYHA) Class III/IV heart failure; Participants with history or presence of second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block; 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; Participants with any of the acute or chronic infections or infection history; Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study; Participants with ANY of the abnormalities in clinical laboratory tests at screening or Day -1, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary. - White blood cell (WBC) <3500/mm3 (<3.5 × 109 cells/L) - Absolute neutrophil count (ANC) <1500/mm3 (<1.5 × 109 cells/L) - Absolute lymphocyte count (ALC) <800/mm3 (<0.8 × 109 cells/L) - Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) level >2 × upper limit of normal (ULN) - Total bilirubin level > 1.5 × ULN; participants with a history of Gilbert’s syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN; - Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. - In the opinion of the investigator, have any clinically significant laboratory abnormality that could affect interpretation of study data or the participant’s participation in the study; Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >470 ms, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST segment and/or T wave changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 470 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant’s eligibility. Computer interpreted ECGs [with abnormal findings] should be overread by an investigator experienced in reading ECGs before excluding a participant; 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; A positive pregnancy test; Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If systolic BP is ≥140 mm Hg or diastolic ≥90 mm Hg, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant’s eligibility.

EU CTIS 2025-520930-44-00