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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Learn How Different Manufactured Products of the Study Medicine Called Ritlecitinib are Taken up Into the Blood in Healthy Adults When Taken on an Empty Stomach or When Taken With a Meal in Healthy Adults.

This research study is looking at how a medicine called ritlecitinib works in the body. Specifically, we want to understand how different ways of making this medicine affect how well it’s absorbed into the blood of healthy adult volunteers. We’ll be comparing what happens when the medicine is taken on an empty stomach versus after a meal. Ritlecitinib is being developed for conditions like ulcerative colitis, Crohn's disease, a type of hair loss called alopecia areata, rheumatoid arthritis, and vitiligo. By doing this study, we hope to find the best way to give the medicine so it can help patients more effectively in the future. This is a very early stage (Phase 1) study.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Pfizer Inc.
Enrolment target
12
Start
25 Oct 2023

What is this study about?

This study is all about understanding how a medicine called ritlecitinib behaves in the human body. Think of it like trying out different types of packaging for a new food product – does it taste better from a tin, a jar, or a box? In this case, we're looking at different manufactured versions of ritlecitinib to see how each one gets absorbed into the bloodstream. We're also checking if taking the medicine with food or without food changes how much of it gets into your system.

Ritlecitinib is a medicine being developed to help people with several health conditions. These include inflammatory bowel diseases like ulcerative colitis and Crohn’s disease, an autoimmune condition causing hair loss called alopecia areata, rheumatoid arthritis which causes joint pain and swelling, and vitiligo which affects skin colour. Understanding how the medicine is absorbed is a really important early step in making sure it works as well as possible for patients.

By carefully studying healthy volunteers, we can learn important information about how the body handles this medicine without the complications that might come from someone who is already unwell. This helps doctors work out the best way for patients to take ritlecitinib in the future, making sure they get the right amount of medicine into their body to potentially help with their condition.

Key takeaways

  • This study is testing a new medicine called ritlecitinib.
  • It's looking at how the medicine is absorbed into the blood.
  • Healthy adult volunteers are needed.
  • The study compares taking the medicine with food versus on an empty stomach.
  • It's an early-stage study to gather important information for future patient treatments.

Who may be eligible?

This study is looking for healthy adult volunteers to take part. This means you should generally be in good health and not have any serious ongoing medical conditions.

You need to be at least 18 years old to participate. There isn't an upper age limit mentioned, but good health is key, regardless of your age.

Both men and women are welcome to join this study. If you're interested, the study team will ask you some questions and do a health check to make sure it's safe for you to take part.

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.

  1. Are you 18 years old or older?
  2. Are you generally in good health?
  3. Are you willing to visit the clinic multiple times?
  4. Are you comfortable with having blood samples taken?
  5. Are you able to follow study instructions carefully?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be helping researchers understand how the study medicine, ritlecitinib, works. You will be asked to visit the study clinic multiple times. During these visits, the study team will take blood samples to measure how much of the medicine is in your blood. You'll also have general health checks, like measuring your blood pressure and heart rate.

The study involves taking different versions of the medicine, both on an empty stomach and after a meal, so you might stay at the clinic for a short period after taking the dose to allow for regular blood tests. The total time you'd be involved in the study, including all visits and follow-ups, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. For you, a potential benefit could be contributing to important medical research that could one day help people with serious conditions. However, there may be no direct health benefit to you personally. Potential risks could include side effects from the study medicine, discomfort from blood tests, or inconvenience from study visits. All potential risks will be fully explained to you before you agree to take part. Remember, your participation is completely voluntary, and you have the right to withdraw from 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.
  • Unverified
    Belgium

Common questions

What is ritlecitinib?

Ritlecitinib is a medicine that is being developed to treat several health conditions like ulcerative colitis, a type of hair loss, and rheumatoid arthritis.

Why is this study being done on healthy people?

By studying healthy people, researchers can understand how the medicine works in the body without other health problems complicating the results. This helps them plan better studies for sick patients later on.

Will I get paid for taking part?

The information provided doesn't mention payment. This is a good question to ask the study team directly.

How long will I be involved in the study?

The total duration of your involvement, including all visits, will be clearly explained by the study team before you join.

What if I change my mind after joining?

You have the right to leave the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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