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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

18 Jul 2025 → ongoing

Decision date (initial)

2025-05-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Others

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.

Secondary objectives 4

1. To estimate the plasma PK parameters of etrasimod following multiple oral doses of etrasimod 2 mg at steady state in lactating women.
2. To estimate the milk-to-plasma drug concentration ratio following multiple oral doses of etrasimod 2 mg at steady state in lactating women.
3. To characterize the safety and tolerability of multiple oral doses of etrasimod 2 mg in lactating women.
4. To estimate the infant dose that would result from etrasimod secretion in breast milk following multiple oral doses of etrasimod 2 mg in lactating women.

Conditions and MedDRA coding

Ulcerative Colitis and immune-mediated inflammatory disorders

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002713-PIP01-19, EMEA-002713-PIP02-21

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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 criteria 17

1. 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. 14. A positive urine drug test. A single repeat for positive drug screen may be allowed.
3. 15. A positive pregnancy test.
4. 16. 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.
5. 17. 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.
6. 6. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
7. 7. 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).
8. 8. History or evidence of hepatitis B or hepatitis C viruses. Hepatitis B vaccination is allowed.
9. 9. Participants with any of the acute or chronic infections or infection history.
10. 10. 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.
11. 11. Evidence of active Mycobacterium tuberculosis (TB) infection in the past. Adequately treated latent TB will be permitted.
12. 12. 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.
13. 13. 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.
14. 2. 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.
15. 3. Participants with history or presence of second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block.
16. 4. 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.
17. 5. Recurrent symptomatic bradycardia or recurrent cardiogenic syncope.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Breast milk etrasimod PK parameters: AUCtau, Cmax, Aebm, Aebm%, Tmax, and CLbm (if data permit).

Secondary endpoints 4

1. Plasma etrasimod PK parameters: AUCtau, Cmax, Tmax, as data permits.
2. MPAUCtau
3. TEAEs, clinical laboratory tests, vital signs, and ECGs
4. BWNID, BWNMD, and BWNIDPCM

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

3 submissions — initial application plus substantial / non-substantial modifications