A study in healthy men to test how BI 1815368 is processed in the body
This clinical trial looks at how a new medicine, known as BI 1815368, behaves inside the human body. It is an early-stage study (Phase 1) designed specifically for healthy men aged 18 or older. Because this medicine is in its early stages of development, scientists need to understand how it travels through the body. They will measure how quickly it is absorbed, how it is broken down, and how it is cleared away. Participants will receive the medicine and be monitored closely by a medical team. Doctors will carry out regular checks, including taking blood and urine samples, to track the medicine safely. Although taking part does not treat any illness, healthy volunteers play a vital role in providing safety data that is needed before the drug can be tested in patients who are unwell.
At a glance
What is this study about?
Before a new medicine can be used to treat patients, scientists must first learn how it behaves in human bodies. This early trial is testing an experimental drug called BI 1815368. The study aims to look at how the body processes the drug, from the moment it enters the system until it leaves.
During the trial, doctors will track what is known as pharmacology. In simple terms, this means watching how the medicine is absorbed into the bloodstream, how it spreads, how the liver or kidneys break it down, and how it is passed out in urine or stool. Collecting this information helps researchers work out the safest and most effective dose for future studies.
Because this is a Phase 1 study, it involves healthy volunteers rather than people with a specific medical condition. Studies like this are an essential stepping stone in medical research. Without the help of healthy volunteers, it would not be possible to create new, safe treatments for illnesses in the future.
Key takeaways
- This is an early-stage safety study testing the experimental drug BI 1815368.
- The study is designed for healthy men aged 18 and over.
- Researchers want to understand how the body absorbs, breaks down, and clears the medicine.
- Taking part involves health screenings, clinic visits, and regular blood and urine tests.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to men aged 18 and older who are in general good health. Because the aim is to see how the drug works in a body unaffected by other illnesses, participants need to have no major ongoing medical conditions.
To keep everyone safe, you may not be able to take part if you take regular prescription medicines, have chronic health problems, or have had recent illnesses. The trial team will carry out health checks to make sure taking part is safe for you.
Volunteers must also be able to travel to the study clinic and attend all planned visits, tests, and monitoring sessions.
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 a man aged 18 or older?
- Are you in generally good health?
- Are you free from major or long-term medical conditions?
- Are you not taking regular prescription medications?
- Are you able to travel to the clinic and attend all scheduled visits?
What does participation involve?
Taking part begins with a screening appointment where doctors check your overall health using routine tests, such as checking your blood pressure, taking blood and urine samples, and recording your heart rhythm (an ECG). If you are suitable and agree to join, you will be given the study drug BI 1815368. You will likely spend time at a specialised research clinic so the medical team can monitor you closely. Staff will take regular blood and urine samples over several hours or days to measure drug levels. After finishing the medication stage, you will have a final check-up to make sure you remain well. The study team will explain the exact number of days and visits before you decide to join.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
Why is this trial only for healthy men?
Early drug studies often start in a small, uniform group to reduce outside variables, such as hormonal changes or pre-existing conditions, making it easier to see how the body handles the drug safely.
Will I get paid for taking part?
Phase 1 trials for healthy volunteers usually offer payments to cover your time, travel expenses, and any inconvenience, but details will be provided by the study team.
Will the study drug make me sick?
As with any new medicine, side effects are possible. The study team monitors you very closely to manage any symptoms quickly and keep you safe.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the study at any point, and you do not need to give a reason.
What happens to the information collected about me?
Your medical details are kept strictly confidential and protected by UK data protection laws. Any published results will not identify you personally.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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