A study in subjects with gout flares that investigates the effect, safety, tolerability, and pharmacokinetics (absorption, distribution, metabolism, and elimination) of a single dose of LEO 158968, a new compound that may potentially be used in the treatment of several autoinflammatory diseases
This research study is for men aged 18 and over who are experiencing gout flares. It's investigating a new medicine called LEO 158968. Researchers want to understand several things: how safe the medicine is, if people can tolerate it well, and how the body absorbs and processes it. This is an early-stage study, meaning it's one of the first times this new medicine is being given to people. The main goal is to see if LEO 158968 could potentially be a treatment for gout flares and similar conditions in the future by testing a single dose. Participants will help researchers learn important information about this new drug.
At a glance
What is this study about?
This study is exploring a new medicine, called LEO 158968, that might one day help people with painful gout flares. Gout flares happen when a substance called uric acid builds up in your body, forming crystals in your joints. This can cause sudden, severe pain, swelling, and redness.
Researchers want to understand how this new medicine works in the body. They'll be looking carefully at how safe it is, whether people have any side effects, and how the body takes in, uses, and gets rid of the medicine. This is an important first step to see if this new medicine could be a good treatment option in the future, not just for gout but possibly for other conditions where the body's immune system mistakenly attacks itself.
Because this is a very early study, called a Phase I study, it means the medicine is new and hasn't been widely tested in people before. The study will involve giving participants a single dose of LEO 158968. The information gathered will be crucial for deciding if this medicine should be studied further.
Key takeaways
- This study is testing a new medicine for gout flares.
- It's an early-stage study focused on safety and how the body handles the medicine.
- Only men aged 18 and over, currently experiencing a gout flare, can participate.
- Participants will receive a single dose of the new medicine.
- Your health will be closely monitored throughout the study.
Who may be eligible?
This study is specifically looking for male volunteers who are at least 18 years old. There is no upper age limit for participating, as long as you meet the other requirements. Participants must be experiencing a gout flare when they join the study.
Other health conditions or medicines you are currently taking might mean you cannot take part. This is to ensure the safety of everyone in the study and to make sure the results are clear. The research team will carefully review your health information to see if this study is suitable for you.
It's important to discuss any health concerns with the study doctor during the screening process. They will explain all the requirements in detail and help you understand if you can join.
- Are you male?
- Are you 18 years old or older?
- Are you currently having a gout flare?
- Are you generally able to attend study visits?
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'll first have screening visits to check if you're suitable for the study. This will likely involve health checks, blood tests, and reviewing your medical history. Once confirmed, you will receive a single dose of the study medicine, LEO 158968. You will be closely monitored by the study team for a period after receiving this dose to check for any immediate effects.
There will be follow-up visits or phone calls to see how you are feeling and to collect more information about the medicine's effects and how your body is handling it. These visits will involve further health checks and possibly more blood tests. The total duration of your participation in the study, from first screening to final follow-up, will be explained fully by the research team.
Potential risks and benefits
Locations (2)
- —Netherlands
- —France
Common questions
What is a 'gout flare'?
A gout flare is a sudden, very painful attack of arthritis, often in the big toe, caused by a buildup of uric acid crystals in a joint.
What does 'early-stage study' mean?
It means this is one of the first times this new medicine is being tested in people to check its safety and how it works in the body.
Will I get better from my gout by being in this study?
The main goal of this study is to gather information about the new medicine. While it might help, there's no guarantee the medicine will improve your gout.
Why is it only for men?
Early studies sometimes focus on one gender to simplify the initial testing. If the medicine proves safe, it may be tested in women in later studies.
Will I have to pay to be in the study?
No, you will not have to pay for any study-related procedures or the medicine. Sometimes, travel expenses may be covered.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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