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Study on How Etrasimod Arginine is Absorbed in Blood and Breast Milk of Healthy Breastfeeding Women with Ulcerative Colitis and Other Inflammatory Disorders

InvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying how the medicine Etrasimod Arginine is absorbed into the blood and breast milk of healthy breastfeeding women. Etrasimod Arginine is a medication that is being researched for its potential use in treating conditions like Ulcerative Colitis and other immune-related inflammatory disorders. The study involves taking multiple doses of this medicine in tablet form.

The main purpose of the study is to understand the amount of Etrasimod Arginine that is secreted into breast milk after taking the medicine regularly. Participants in the study will be healthy women who are breastfeeding and are at least 12 weeks postpartum. They will be required to temporarily stop breastfeeding their infants for a period of 21 days while they take the medication and continue to express breast milk to maintain lactation.

Throughout the study, the participants will take the medicine orally and their blood and breast milk will be tested to measure how much of the medicine is present. This will help researchers learn more about the safety and behavior of Etrasimod Arginine in the body, particularly in breastfeeding women. The study aims to provide valuable information that could contribute to the development of treatments for Ulcerative Colitis and similar conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to sign an informed consent document. This confirms your understanding and agreement to participate in the study.
You must be a healthy lactating woman, actively breastfeeding or expressing breast milk, at least 12 weeks post-partum, and not currently pregnant. A negative pregnancy test is required.
Your age should be between 18 to 55 years, with a body mass index (BMI) of 16-35 kg/m² and a total body weight greater than 45 kg (99 lb).
Step 2
Preparation for medication
You will need to temporarily discontinue breastfeeding your infant for a total of 21 days. This period starts from the evening before Day 1 and continues until 14 days after the last dose.
You must be willing to regularly pump your breasts and express breast milk according to a schedule designed to maintain lactation until the completion of breast milk collection.
Step 3
Medication administration
You will take the study medication, etrasimod arginine, in the form of a tablet.
The dosage is 2 mg, taken orally once daily.
The medication will be administered for a specified duration to reach a steady state in your system.
Step 4
Monitoring and data collection
Throughout the study, your health will be monitored through clinical laboratory tests, vital signs, and electrocardiograms (ECGs).
The study aims to evaluate the amount of etrasimod secreted in human breast milk and its uptake into your blood.
Regular assessments will be conducted to measure various parameters related to the medication in your breast milk and blood.
Step 5
Completion of the study
After the study period, you will resume breastfeeding as per your normal routine.
Final assessments will be conducted to ensure your health and well-being post-study.

Who can join the trial?

9 criteria

Must be a healthy woman, as determined by a medical check-up, including medical history, physical examination, lab tests, vital signs, and heart test (ECG).
Must be lactating, which means actively breastfeeding or expressing breast milk.
Must be at least 12 weeks post-partum, meaning 12 weeks after giving birth.
Must not be currently pregnant and must have a negative pregnancy test.
Must be between 18 to 55 years old at the time of signing the consent form.
Must have a body mass index (BMI) between 16 and 35. BMI is a measure of body fat based on height and weight.
Must weigh more than 45 kg (99 lb).
Must be willing to temporarily stop breastfeeding their infants for 21 days, starting the evening before the first day of the study until 14 days after the last dose.
Must be willing to regularly pump and express breast milk according to a schedule to maintain milk production during the study.

Who cannot join the trial?

3 criteria

Patients who are not lactating women cannot participate. Lactating means women who are currently breastfeeding.
Patients who are male cannot participate.
Patients who do not have Ulcerative Colitis or other immune-mediated inflammatory disorders cannot participate. Immune-mediated inflammatory disorders are conditions where the immune system causes inflammation in the body.

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Investigated drugs

Etrasimod is a medication being studied to understand how much of it passes into breast milk when taken by healthy lactating women. It is taken orally and is being tested to see how it behaves in the body over time. This study aims to ensure that the medication is safe for both the mother and the breastfeeding child by examining its presence in breast milk. Etrasimod is being evaluated for its potential effects and safety in this specific group of women.

Etrasimod Arginine

What is already known about the treatment

Etrasimod – Etrasimod is administered orally in the form of a tablet. It is currently being studied in clinical trials, particularly focusing on its effects in healthy lactating women. The main therapeutic indications for etrasimod include the treatment of ulcerative colitis and other immune-mediated inflammatory disorders. At the molecular level, etrasimod works by modulating the activity of certain immune cells, helping to reduce inflammation in the body. It is classified pharmacologically as a selective sphingosine 1-phosphate (S1P) receptor modulator.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon, also known as the large intestine. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. The inflammation causes the colon to empty frequently, resulting in diarrhea. Over time, the persistent inflammation can lead to the formation of ulcers, which are small open sores that can bleed and produce pus. The progression of ulcerative colitis can vary, with periods of active symptoms followed by times of remission.