A study in healthy men to test how well different doses of BI 3802876 are tolerated
This research study is inviting healthy men to take part. It's designed to test a new, unnamed medicine called BI 3802876. This is a very early-stage study, meaning it's the first time this medicine will be given to people. The main goal is to find out if it's safe for humans and how well different amounts (doses) of the medicine are tolerated by the body. Researchers will carefully check for any side effects and how the medicine behaves in the body. Taking part in studies like this helps us learn crucial information about new medicines, which is an important step before they can potentially be used to treat illnesses in the future.
At a glance
What is this study about?
Imagine scientists have developed a brand new key, but they don't yet know if it will unlock a door smoothly or if it might get stuck. This study is similar: it's about a brand new medicine, or 'key,' called BI 3802876.
This is a very early test, sometimes called a 'Phase 1' study. It's the first time this new medicine will be given to people. The main aim is to see if it's safe and how healthy men react to different amounts (doses) of it. The researchers will be looking very closely for any side effects and understanding how the medicine moves through and out of the body. They want to make sure it's well-tolerated before more research can be done.
By taking part, healthy volunteers play a crucial role. The information gathered in this study helps us understand the new medicine better. This is a vital first step in developing medicines that could one day help people with various health conditions, even though this study doesn't focus on treating a specific illness.
Key takeaways
- This study is testing a brand new medicine called BI 3802876 for the first time in people.
- It's open to healthy men, aged 18 and over.
- The main aim is to check if the medicine is safe and how the body handles different amounts.
- You won't be treated for an illness; you'd be helping medical research.
- Taking part would involve regular clinic visits, blood tests, and monitoring.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is specifically looking for volunteers who are healthy men. You must be at least 18 years old to take part. There is no upper age limit, as long as you are considered generally healthy.
To be considered 'healthy' for this kind of study, doctors will do several checks. This usually means you don't have any major ongoing health conditions and aren't taking regular medication that might interfere with the study medicine. They will check your medical history, do a physical exam, and might take blood and urine samples.
Because this is the very first time this medicine is being given to humans, it's very important that participants are in good health. This helps the researchers clearly see the effects of the new medicine without other health issues making things unclear.
- Are you male?
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Do you have any major ongoing medical conditions (e.g., heart disease, diabetes, lung problems)? (If yes, you may not be eligible.)
- Are you currently taking any regular prescription medicines?
- Are you willing to commit to multiple clinic visits and possibly overnight stays?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you take part, you would receive doses of the new medicine, BI 3802876, over a period of time. This would involve regular visits to the study clinic, and you might need to stay overnight or for several days at different points. During these visits, the study team would perform various assessments. This includes physical checks, taking blood and urine samples, and monitoring your heart activity with an ECG. They will keep a close eye on you for any side effects. After receiving the medicine, there will be follow-up appointments to ensure you are well and to collect final information. The total length of your involvement, including all visits and follow-ups, would be explained in detail before you agree to participate.
Potential risks and benefits
Locations (1)
- —Belgium
Common questions
What is a 'healthy volunteer' study?
It's a study where people who are generally well, without any major health problems, take part. This helps researchers understand how a new medicine works in a healthy body.
What does 'first administration to humans' mean?
It means this is the very first time this specific medicine has been given to people. It has been tested in labs and animals, but never before in humans.
Why is it only for men?
Sometimes, early studies focus on one sex to simplify the initial testing and gather clear safety information before expanding to a wider group later on.
Will I be given the actual medicine or a dummy pill?
In studies like this, participants usually receive the actual medicine to test its safety and how it works. The study team will explain if any participants might receive a placebo (dummy pill).
Will I get paid for taking part?
Many early-stage studies offer payment for your time and inconvenience. The study team will provide full details about any compensation available.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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