Study on Etrasimod Arginine for Patients with Ulcerative Colitis, Alopecia Areata, Atopic Dermatitis, and Eosinophilic Esophagitis

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What is this study about?

This clinical trial is focused on studying a group of diseases known as immune-mediated inflammatory disorders. These include conditions like ulcerative colitis, alopecia areata, atopic dermatitis, and eosinophilic esophagitis. The study is testing a medication called Etrasimod Arginine, which is being developed by Pfizer Inc. The medication is being tested in the form of mini tablets, which are small tablets that can be mixed with different foods or water.

The purpose of the study is to learn more about how the body absorbs the Etrasimod Arginine mini tablets when they are mixed with different foods like applesauce, chocolate pudding, yogurt, or just water. The study will also look at how the mini tablets taste when mixed with these foods. Participants in the study will take a single dose of the mini tablets in different forms, and researchers will compare how the body absorbs the medication in each case.

The study involves healthy adult participants who will take part in a series of tests to see how the medication is absorbed and how it tastes. The study will help researchers understand the best way to deliver the medication to patients in the future. Participants will be monitored for any side effects and will provide feedback on the taste and feel of the mini tablets. This information will be used to improve the medication for future use in treating the diseases being studied.

1 joining the study

Upon joining the study, participants will be required to provide signed informed consent, confirming their understanding and agreement to participate in the trial.

Participants must be at least 18 years old and in good health, as determined by a medical evaluation, which includes a detailed medical history, a full physical exam, blood pressure and pulse rate measurement, clinical laboratory tests, temperature check, and a 12-lead electrocardiogram (ECG).

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility, which includes checking body mass index (BMI) between 16 to 32 kg/m² and a total body weight greater than 50 kg (110 lb).

Participants must be willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other study procedures.

3 medication administration

Participants will receive a single dose of etrasimod arginine in the form of a 2 mg mini tablet.

The mini tablet will be administered orally and may be mixed with water, applesauce, chocolate pudding, or yogurt to evaluate its taste and relative bioavailability compared to the clinical immediate-release (IR) tablets under fasted conditions.

4 monitoring and evaluation

Participants will be monitored for plasma levels of etrasimod to assess the drug’s absorption and maximum concentration in the blood.

Additional assessments will include monitoring heart rate, any adverse effects, clinical laboratory abnormalities, vital signs, physical examinations, and 12-lead ECGs.

5 palatability assessment

Participants will complete a questionnaire to evaluate the palatability of the mini tablet, focusing on aspects such as mouth feel, bitterness, any burning sensation in the mouth or throat, and overall liking.

6 completion of the study

Upon completion of all assessments and evaluations, participants will have fulfilled their role in the study.

The estimated end date for the trial is October 17, 2023.

Who Can Join the Study?

  • Participants must be 18 years or older and considered healthy based on a medical check-up. This includes a review of their medical history, a physical exam, and tests like blood pressure, heart rate, lab tests, body temperature, and an ECG (a test that checks the heart’s electrical activity).
  • Participants should have a Body Mass Index (BMI) between 16 and 32 kg/m2. BMI is a measure of body fat based on height and weight.
  • Participants must weigh more than 50 kg (110 pounds).
  • Participants should be willing and able to attend all scheduled visits, follow the treatment plan, undergo lab tests, and adhere to lifestyle guidelines and other study procedures.
  • Participants must be able to provide signed informed consent, which means they understand the study and agree to participate.

Who Cannot Join the Study?

  • Patients with immune-mediated inflammatory disorders such as ulcerative colitis, alopecia areata, atopic dermatitis, and eosinophilic esophagitis cannot participate. These are conditions where the immune system attacks the body’s own tissues.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Pfizer Clinical Research Unit Brussels Belgium

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
03.07.2023

Trial locations

Investigated drugs:

Etrasimod is a medication being studied to understand how well it is absorbed by the body when taken in different forms. In this trial, participants took etrasimod in the form of mini tablets. These mini tablets were mixed with different types of food, like applesauce, chocolate pudding, and yogurt, to see how these combinations affect the medication’s absorption compared to taking the tablets with just water. The goal is to find out if the food affects how much of the medication gets into the bloodstream and how quickly it happens. This information can help determine the best way to take etrasimod for it to work effectively.

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It involves continuous inflammation of the innermost lining of the large intestine, leading to ulcers. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of exacerbation and remission. Over time, the inflammation can cause the colon to become less effective at absorbing nutrients and water. This condition is part of a group of diseases known as inflammatory bowel disease.

Alopecia Areata – Alopecia areata is an autoimmune disorder characterized by sudden, patchy hair loss on the scalp or other areas of the body. The immune system mistakenly attacks hair follicles, leading to hair loss. The progression of the disease can vary, with some individuals experiencing regrowth of hair while others may have persistent hair loss. The condition can occur at any age and affects both men and women. It is not associated with any physical pain or other health issues. The extent of hair loss and regrowth varies greatly among individuals.

Atopic Dermatitis – Atopic dermatitis, commonly known as eczema, is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood. The skin becomes red and irritated, and scratching can lead to further skin damage and infection. The condition tends to flare up periodically, with symptoms worsening at times. Environmental factors, allergens, and stress can trigger or exacerbate symptoms. It is part of a group of conditions known as atopic diseases, which also includes asthma and allergic rhinitis.

Eosinophilic Esophagitis – Eosinophilic esophagitis is a chronic immune system disease in which eosinophils, a type of white blood cell, build up in the esophagus. This accumulation leads to inflammation and damage to the esophageal tissue. Symptoms can include difficulty swallowing, food impaction, and chest pain. The disease can progress to cause narrowing of the esophagus, making it difficult for food to pass through. It is often associated with food allergies and other allergic conditions. The condition can affect individuals of all ages, but it is more commonly diagnosed in children and young adults.

Trial ID:
2023-504411-32-00
Protocol code:
C5041034
Trial Phase:
Human Pharmacology (Phase I) – Other

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