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A plain-language summary of the goals, design and what participants do
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.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
3 criteria
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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 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 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, 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 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.
Other trials in this disease – keep exploring while you decide
Austria
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FranceThe Netherlands
Italy
Belgiumsourced from the EU Clinical Trials Register and site verification
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