Not recruiting

A study comparing how ritlecitinib capsules work when sprinkled on food versus swallowed whole and with or without food in healthy adults

InvestigationalNo placebo

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What is this trial about?

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

This study involves Ritlecitinib, a medicine being tested for several conditions including Alopecia Areata, which is a condition that causes hair loss in patches, Rheumatoid Arthritis, which is a disease where the body's immune system attacks the joints causing pain and swelling, Vitiligo, which is a condition that causes loss of skin color in patches, Ulcerative Colitis, which is a disease that causes inflammation and sores in the lining of the large intestine, and Crohn's Disease, which is a condition that causes inflammation of the digestive tract. The medicine comes in the form of a hard capsule that can be taken by mouth. The study will look at how the body absorbs the medicine when the capsule contents are sprinkled on different foods compared to when the capsule is swallowed whole.

The purpose of this study is to measure how much of the medicine gets into the bloodstream when the capsule is opened and sprinkled on applesauce, strawberry jam, or yoghurt compared to swallowing the capsule whole without food, and also to see how eating food affects the amount of medicine that gets into the bloodstream when the capsule is swallowed whole. This information is important for understanding different ways the medicine can be taken, especially for people who may have difficulty swallowing capsules. The study will involve healthy adult participants who will receive a 30 mg dose of the medicine in different ways during the study.

Participants will take part in a study where they will receive the medicine in different forms on different occasions, allowing researchers to compare how the body processes the medicine under various conditions. Blood samples will be collected to measure the amount of medicine in the bloodstream over time. The study will monitor participants for any unwanted effects that may occur during the treatment period.

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
Initial study period preparation
After joining the study, your participation will begin with preparation for the treatment periods.
This is a crossover study, which means you will receive the study medication in different ways during separate treatment periods.
The study involves taking ritlecitinib, which is provided as a hard capsule that can be taken by mouth.
Step 2
Treatment periods with ritlecitinib
You will receive ritlecitinib at a dose of 30 mg during each treatment period.
The medication will be given in different forms across the treatment periods. In some periods, you will take the intact capsule as a whole. In other periods, the capsule contents will be sprinkled on food such as applesauce, yoghurt, or strawberry jam.
Some doses will be taken while fasting, meaning you will not eat before taking the medication. Other doses will be taken with food to assess how eating affects the medication in your body.
The order in which you receive these different forms will be assigned randomly.
Step 3
Blood sample collection
During each treatment period, blood samples will be collected from you at specified times.
These samples are used to measure the amount of ritlecitinib in your blood over time.
The measurements include AUCinf, which represents the total amount of medication in your blood over time, and Cmax, which is the highest level of medication reached in your blood.
Step 4
Safety monitoring throughout the study
Your health will be monitored continuously during the study.
Any adverse events, which are unwanted or harmful effects that occur during the study, will be recorded and assessed.
Monitoring includes physical examinations, measurement of blood pressure and pulse rate, laboratory tests, and electrocardiogram (a test that measures the electrical activity of your heart).
Step 5
Completion of all treatment periods
You will complete all assigned treatment periods as part of the crossover design.
Each period will be separated by a time interval to allow the medication to be cleared from your body before starting the next period.
After completing all treatment periods and final assessments, your participation in the study will be complete.

Who can join the trial?

5 criteria

You must be 18 years of age or older at the time of screening
You must be a healthy person as confirmed by your doctor through a complete medical history review, physical examination (which includes checking your blood pressure and heart rate), laboratory blood tests, and a heart tracing test called an ECG (a test that records the electrical activity of your heart)
Your BMI (body mass index, which is a measure that uses your height and weight to determine if you are in a healthy weight range) must be between 16 and 32 kg/m2, and you must weigh more than 45 kilograms (99 pounds)
You must be willing and able to follow all scheduled appointments, the treatment plan, laboratory tests, lifestyle requirements, and other study procedures
You must be able to understand the study and provide your signed informed consent (a document you sign to show you agree to participate after understanding what the study involves)

Who cannot join the trial?

7 criteria

The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why someone cannot participate are not available in this data.
Generally, clinical trials have exclusion criteria to ensure participant safety and study accuracy, but these specific details would need to be obtained from the complete study documentation.
If you have allergies (reactions your body has to certain substances that can cause symptoms like rash, swelling, or breathing problems) to the study medication or its ingredients, you may not be able to participate.
If you are pregnant (carrying a baby) or breastfeeding (feeding a baby with milk from your breast), you may not be eligible for this study.
If you have serious health conditions affecting your liver (the organ that cleans your blood and helps digest food) or kidneys (the organs that filter waste from your blood and make urine), you may not be able to join.
If you are taking certain medications that could interfere with the study drug, you may be excluded from participation.
If you have had recent infections (illnesses caused by germs like bacteria or viruses) or have a weakened immune system (your body's defense system against germs and disease), you may not qualify.

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Investigated drugs

Ritlecitinib is an investigational medication being tested in this clinical trial. In this study, participants will receive ritlecitinib in capsule form. The medication will be given in different ways to compare how the body absorbs it. Some participants will take the capsule whole, while others will open the capsule and sprinkle its contents on different foods such as applesauce, strawberry jam, or yogurt. The study will also look at whether eating food affects how well the body absorbs the medication when taken as a whole capsule.

What is already known about the treatment

Ritlecitinib – Ritlecitinib is an investigational medication being studied in capsule form that can be taken by mouth, either swallowed whole or sprinkled on soft foods like applesauce, yogurt, or jam. It is currently being tested in clinical trials for the treatment of several conditions including alopecia areata (a type of hair loss), rheumatoid arthritis (joint inflammation), vitiligo (skin pigmentation disorder), ulcerative colitis, and Crohn's disease (inflammatory bowel diseases). The drug works at the molecular level by blocking specific enzymes called JAK3 and TEC family kinases, which play a role in inflammation and immune system responses. Ritlecitinib belongs to a class of medications known as kinase inhibitors, which help reduce abnormal immune system activity that contributes to these various inflammatory and autoimmune conditions.

Investigated diseases

Alopecia Areata
Alopecia Areata is a condition where the immune system mistakenly attacks hair follicles, causing hair loss. The hair loss typically occurs in round patches on the scalp, but it can affect any area of the body where hair grows. The condition can develop suddenly over just a few days or weeks. In some cases, the hair may grow back on its own, while in others, the hair loss may progress to larger areas. The severity varies from person to person, with some experiencing only small patches while others may lose all scalp hair or even all body hair. The condition can occur at any age and affects both men and women equally.
Rheumatoid Arthritis
Rheumatoid Arthritis is a chronic condition where the immune system attacks the lining of the joints, causing inflammation. The disease typically affects joints on both sides of the body, such as both wrists, hands, or knees. Symptoms include joint pain, swelling, stiffness, and warmth, which are often worse in the morning or after periods of rest. Over time, the inflammation can damage cartilage and bone within the joints, leading to joint deformity. The condition may also cause fatigue, low-grade fever, and loss of appetite. Rheumatoid Arthritis can also affect other organs and tissues in the body beyond the joints.
Vitiligo
Vitiligo is a condition where the skin loses its pigment cells, resulting in white patches on various parts of the body. The patches occur because cells called melanocytes, which produce skin color, are destroyed. The condition can affect any area of the skin, but it commonly appears on the face, hands, arms, and feet. The white patches may start small and gradually spread over time, though the rate and extent of color loss is unpredictable. Hair growing in affected areas may also turn white or gray. Vitiligo can begin at any age but often appears before the age of 30.
Ulcerative Colitis
Ulcerative Colitis is a chronic condition that causes inflammation and ulcers in the inner lining of the colon and rectum. The inflammation typically begins in the rectum and may spread continuously to involve other parts of the colon. Symptoms include diarrhea often with blood or pus, abdominal pain and cramping, rectal pain, and urgent need to have bowel movements. The condition usually develops gradually rather than suddenly. People with Ulcerative Colitis experience periods of flare-ups when symptoms worsen and periods of remission when symptoms improve or disappear. The severity ranges from mild to severe, affecting quality of life differently for each person.
Crohn's Disease
Crohn's Disease is a chronic condition that causes inflammation in any part of the digestive tract from the mouth to the anus. Unlike Ulcerative Colitis, the inflammation in Crohn's Disease can occur in patches with healthy tissue in between and affects all layers of the bowel wall. Common symptoms include persistent diarrhea, abdominal pain and cramping, blood in the stool, reduced appetite, and weight loss. The inflammation can lead to complications such as narrowing of the bowel or abnormal connections between different parts of the intestine. Symptoms may develop gradually or appear suddenly. The condition typically involves periods of active disease alternating with periods of remission.