Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

B7981078: A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PEDIATRIC RITLECITINIB (PF-06651600) SPRINKLED IN APPLESAUCE, YOGHURT AND STRAWBERRY JAM RELATIVE TO INTACT BLEND-IN CAPSULE OF RITLECITINIB AND THE EFFECT OF FOOD ON THE BIOAVAILABILITY OF THE CAPSULE DOSAGE FORMULATION OF RITLECITNIB IN HEALTHY ADULT PARTICIPANTS

This research is focused on a medication called ritlecitinib, which is being investigated for conditions like alopecia areata, rheumatoid arthritis, vitiligo, ulcerative colitis, and Crohn's disease. This particular study is a 'Phase 1' study, which means it's one of the first steps in testing a new medicine in people. We want to understand how your body takes in and uses ritlecitinib when it's given in different ways. Specifically, we'll compare taking the medicine mixed into applesauce, yoghurt, or jam, versus taking it as a standard capsule. We'll also look at whether eating food affects how well your body absorbs the capsule form of the medicine. The aim is to find the best and easiest way to give this medicine, especially for children who might find swallowing capsules difficult.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

20 Mar 2023

Alopecia Areata Rheumatoid Arthritis Vitiligo Ulcerative Colitis and Crohn's Disease

What is this study about?

This study is all about a medicine called ritlecitinib, which is currently being researched for several different health conditions, including some that affect your immune system, like alopecia areata (hair loss), rheumatoid arthritis (joint pain), vitiligo (skin discolouration), and gut conditions like ulcerative colitis and Crohn's disease.

Because this medicine might be used by children in the future, it's important to know the best way for them to take it, especially if they can't swallow pills. That's why this study is exploring different ways to give ritlecitinib, such as mixing it with foods like applesauce, yoghurt, or jam. We need to check if mixing it with these foods changes how much of the medicine your body absorbs compared to taking it as a regular capsule. We're also looking at whether simply having food in your stomach when you take the capsule makes a difference.

The main goal is to understand how well and how quickly your body absorbs the medicine in these different situations. This information is really important for doctors and researchers to decide the best way to give ritlecitinib so it can work effectively and safely, especially for younger patients or those who have trouble swallowing capsules. This is a very early-stage study, designed to get basic information about the medicine.

Key takeaways

The study tests how a new medicine, ritlecitinib, is absorbed by the body.
It compares taking the medicine as a capsule versus mixed in with foods like applesauce.
This research aims to find easier ways for people (especially children) to take the medicine.
It's an early-stage study in healthy adults, not intended to treat an illness.
Participation involves taking the medicine in different ways and having blood tests.
You will be closely monitored for any side effects throughout the study.

Who may be eligible?

This study is looking for healthy adults to take part. Being healthy means you don't have any major medical conditions that could interfere with the study or be affected by the medicine.

To join, you need to be at least 18 years old. There's no upper age limit, so suitable adults of any age can be considered. Both men and women are welcome to participate in this study.

There will be other detailed checks to make sure the study is safe for you and that the results will be clear. A doctor at the study site will go through these with you to confirm if you are a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you generally healthy?
Are you able to attend several study visits?
Are you comfortable with having blood samples taken?
Do you understand the purpose of this study is to gather information, not to treat a health condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the medicine, ritlecitinib, in a few different ways over several visits. You might take it as a capsule, or mixed with applesauce, yoghurt, or jam. These will be given at different times.

Throughout the study, you'll have regular check-ups, which will include blood tests to measure how much of the medicine is in your body. We'll also be carefully monitoring you for any side effects or changes to your health. The study involves a 'crossover' design, meaning you'll get the different ways of taking the medicine at different times, with breaks in between. The total duration of your participation, including all visits and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For you, the main benefit is contributing to medical knowledge that could help future patients, especially children, take this new medicine more easily and safely. You'll also receive regular medical check-ups. Potential risks might include discomfort from blood draws, or experiencing side effects from the medicine, none of which are fully known yet as it's an early-stage study. Any side effects will be closely monitored. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is ritlecitinib?

Ritlecitinib is a new medicine being tested for several conditions, including certain types of hair loss, joint pain, skin colour changes, and gut problems. This study is an early step in understanding how it works.

Why is it important to mix the medicine with food?

Mixing the medicine with foods like applesauce, yoghurt, or jam might make it easier to take, especially for children who may struggle to swallow pills. We need to check if this changes how your body uses the medicine.

Will I get the medicine for my condition?

This study is for healthy volunteers to understand the medicine better. It is not designed to treat specific conditions listed like alopecia areata or rheumatoid arthritis.

How many times will I have to visit the study clinic?

The study involves several visits where you'll receive the medicine and have blood tests. The exact number and length of visits will be explained to you by the study team.

What does 'Phase 1' mean?

Phase 1 means this is one of the very first studies in people. We're mainly checking how safe the medicine is and how the body handles it, rather than if it treats a specific illness.