An open-label, randomized, single-dose, two-period, two-treatment, crossover bioequivalence study with GP-IMP-001 in healthy male volunteers under fasting conditions.
This research is looking at a new version of a medicine called GP-IMP-001. We want to make sure it's just as effective and safe as the original medicine already used to treat conditions like severe rheumatoid arthritis (a joint problem), certain types of arthritis in children, serious skin problems like psoriasis, and Crohn's disease (a bowel condition). This is a very early stage study, called a Phase I, focusing on how the body handles the medicine. Healthy adult men will take the medicine on an empty stomach, and we will compare two types of the medicine to see how they behave in the body. This helps ensure future patients get the best possible treatment.
At a glance
What is this study about?
This study is about a new version of a medicine called GP-IMP-001. Imagine you have a popular brand of a drink, and a new company makes their own version. This study is like checking if the new drink tastes exactly the same and has the same effect as the original. In medical terms, we call this a "bioequivalence study." This means we want to see if the new GP-IMP-001 medicine is absorbed into the body and works in the same way as the already approved version.
Why does this matter? This medicine is designed to help people with some really serious conditions. These include active rheumatoid arthritis and a type of arthritis that affects children, severe psoriasis (a skin condition that can be very uncomfortable and disabling), and Crohn’s disease (a long-term condition that causes inflammation of the digestive system). For many of these conditions, people have already tried other treatments that haven't worked well enough.
By ensuring this new version of GP-IMP-001 acts in the same way as the original, we can be confident that it will be just as effective and safe for future patients who need it. This type of research is a vital step in making sure new medicines are reliable and can eventually help many people feel better.
Key takeaways
- This study is testing a new version of a medicine for severe diseases.
- It aims to confirm if the new medicine works the same as an existing one.
- Only healthy adult men are invited to participate.
- Participants will take the medicine on an empty stomach during clinic visits.
- Your involvement helps advance medical research for future patients.
Who may be eligible?
To take part in this study, you need to be a healthy adult man. This means you should generally be in good health and not have any serious medical problems. Researchers will check this carefully with medical tests and questions.
At this stage, the study is only looking for men aged 18 years and older. There isn't an upper age limit mentioned, but you would still need to meet the 'healthy' requirement. This is because men's bodies often process medicines in a similar way, and by focusing on one group, researchers can get clearer results about how the medicine works.
It's important to remember that this study is for healthy volunteers, not people who currently have the conditions the medicine is designed to treat. The purpose here is to see how the new medicine behaves in the body without other health problems affecting the results.
- Are you a man?
- Are you 18 years old or older?
- Are you generally in good health?
- Do you not have active rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriasis, or Crohn's disease?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will visit the study clinic two times for treatment, with a break in between. On each visit, you will receive a single dose of one of the two types of the GP-IMP-001 medicine. You will need to take the medicine on an empty stomach. During your visits, medical staff will carefully monitor you and take blood and urine samples at different times to see how your body handles the medicine. This process helps them compare how the two versions of the medicine work. The exact number of visits, how long each visit lasts, and the total time you'll be involved in the study will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Czechia
Common questions
What is the main goal of this study?
The main goal is to check if a new version of a medicine (GP-IMP-001) works in the body the same way as an already approved version.
Who can take part in this study?
Healthy men, aged 18 years and older, are eligible to participate in this study.
Will I get 'better' from taking this medicine?
This study is for healthy volunteers, so you won't get better from a disease. Your participation helps researchers learn more about the medicine to help future patients who are unwell.
What does 'fasting conditions' mean?
It means you will need to take the medicine on an empty stomach, usually meaning no food or drink (except water) for a certain number of hours before.
Is this medicine already used for patients?
An existing version of this medicine is used for patients. This study is testing a new version to ensure it is just as good as the original.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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