Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Study to evaluate food effect on the pharmacokinetics of mesalazine oral formulation in healthy volunteers.

This research study is designed to understand how food affects a medicine called mesalazine, which is often used to treat a bowel condition called ulcerative colitis. We want to see how much of the medicine gets into the body and how quickly when taken after eating, compared to taking it without food. To do this, we're inviting healthy volunteers to take part. The information we gather from this study will help doctors and patients understand the most effective way to take mesalazine, making sure it works as well as possible for people who need it. This type of study is an early step in testing medicines to understand how they work in the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Faes Farma S.A.

Enrolment target

Start

18 Oct 2024

Ulcerative colitis

What is this study about?

This study is all about a medicine called mesalazine. Mesalazine is a very common treatment for a long-term bowel condition called ulcerative colitis. If you have ulcerative colitis, your large bowel can become inflamed, causing symptoms like tummy pain and diarrhoea. Medicines like mesalazine help to calm this inflammation.

When you take any medicine, your body has to absorb it first for it to work. What you eat and when you eat it can sometimes change how well your body absorbs a medicine. In this study, we want to find out if taking mesalazine with food changes how it gets into the body compared to taking it on an empty stomach. We call this a 'food effect' study.

By understanding how food affects mesalazine, doctors can give clearer advice on the best way for patients to take their medication. This could help make sure the medicine works as effectively as possible for people with ulcerative colitis, helping them to feel better.

Key takeaways

This study investigates how food affects a common ulcerative colitis medicine.
It aims to find the best way to take mesalazine for maximum benefit.
Healthy volunteers are needed, aged 18 and over.
Participation involves taking the medicine and having blood tests to track absorption.
The findings could improve treatment for people with ulcerative colitis.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy volunteers. This means you should not have any serious ongoing health conditions. We are looking for people aged 18 or older – there's no upper age limit for taking part.

To be considered, both men and women can join. The study team will check your general health to make sure it's safe for you to participate and that you fit the study's specific requirements. They will ask you questions about your medical history and might do some simple health checks.

Remember, even if you think you're healthy, the study team will need to confirm this with their own tests and questions. This is to ensure the safety of all participants and to get the most accurate results for the study.

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?
Do you consider yourself generally healthy, without major ongoing health problems?
Are you able to attend several study visits, potentially over a few weeks or months?
Are you comfortable with having blood samples taken?
Are you a man or a woman?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the mesalazine medicine on specific days, both with a meal and without. You'll likely need to visit the study clinic or hospital several times. On these visits, healthcare professionals will monitor you and take blood samples at different times after you've taken the medicine. This helps them measure how the medicine is absorbed.

The study will involve taking the medicine and having these checks over a certain period. The exact number of visits, the length of each visit, and the total time you'll be involved in the study will be explained in detail by the study team. You won't be given any other treatments during your participation that could interfere with the study medicine.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the information gained could help many people with ulcerative colitis by improving how their medication is used. While this study uses a commonly used medicine, side effects can occur, and you might experience discomfort from blood tests. All potential risks will be fully explained by the study team before you decide to join. Remember, you can always change your mind and 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.

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Unverified
Spain

Common questions

Why is this study only looking at healthy volunteers?

Studies like this often use healthy volunteers first to clearly understand how the medicine works in the body without other health conditions affecting the results.

What is ulcerative colitis?

Ulcerative colitis is a long-lasting condition where the lining of the large bowel (colon and rectum) becomes inflamed and develops tiny ulcers.

Will I receive any money for taking part?

Often, studies like this offer payment for your time and inconvenience, but this will be clearly explained by the study team.

How long will I need to be involved in the study?

The total length of your involvement and the number of visits will be explained in full detail by the study team before you decide to join.

Can I eat normally while on the study?

You will be given specific instructions about when and what you can eat, especially around the times you take the study medicine. Otherwise, you'll likely maintain your usual diet.