A phase I, open-label, two-arm, non-randomised trial to investigate the metabolism and pharmacokinetics of a single dose of BI 764198 (C-14) administered as oral solution using two different approaches in healthy male volunteers.
This is a very early study to understand a new medicine called BI 764198. Researchers want to see how the body handles this medicine after someone takes a single dose. They will be measuring how much of the medicine leaves the body through urine and faeces. To do this, a special, traceable version of the medicine (C-14) will be used. The study involves healthy male volunteers and aims to learn about the medicine's journey inside the body, including how quickly it's absorbed and how long it stays in the blood. This information is key for developing the medicine further.
At a glance
What is this study about?
This study is an early step in testing a new medicine called BI 764198. It's a 'Phase 1' study, which means the main goal is to understand how the medicine behaves in the body, rather than treating an illness. Think of it like learning how a car works before driving it on a long journey. Researchers want to find out how the medicine is taken up by the body and how it eventually leaves.
To do this, healthy male volunteers will take a single dose of BI 764198. This special version of the medicine contains a tiny, safe amount of a tracer (like a fluorescent dye you can't see) called C-14. This tracer allows researchers to carefully track the medicine's journey. They will collect urine and faeces samples to measure exactly how much of the medicine leaves the body and how long it takes.
They will also take blood samples to see how much of the medicine gets into the bloodstream and how long it stays there. This helps them understand how quickly the body processes the medicine. All this information is really important for deciding the best way to give the medicine and what doses might be helpful in future studies.
Key takeaways
- This is an early study (Phase 1) of a new medicine, BI 764198.
- It aims to understand how the body processes and gets rid of the medicine.
- Healthy male volunteers aged 18 and over are needed.
- You'll take a single dose of the medicine with a special tracer (C-14).
- Researchers will collect blood, urine, and faeces samples to track the medicine.
- Your participation helps advance future medical research.
Who may be eligible?
To be able to take part in this study, you need to be a healthy man, aged 18 or over. This study is specifically looking for people who are in good general health.
Being 'healthy' generally means you don't have any significant ongoing medical conditions, you're not taking regular medications (unless approved by the study doctor), and your general physical health is good, as determined by a medical check-up.
More detailed checks will be done by the study team to make sure it's safe for you to participate.
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?
- Are you 18 years old or older?
- Are you generally in good health, without any significant ongoing medical conditions?
- Are you willing to provide blood, urine, and faeces samples regularly?
What does participation involve?
If you decide to take part, you will receive a single dose of the study medicine, BI 764198, given as a liquid solution that you drink. This medicine will contain a special marker that allows researchers to track it. Over a period of time after taking the medicine, the research team will collect samples of your urine and faeces. They will also take blood samples at specific times.
The purpose of these collections is to measure how much of the medicine leaves your body and how long it stays in your system. The total number of visits and the overall length of time you'll be involved in the study will be explained in detail by the study team, but typically, these early-stage studies can involve several visits or even a short stay at a clinic.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is the main goal of this study?
The main goal is to understand how a new medicine, BI 764198, is handled by the body from the moment it's taken until it leaves, by tracking it in urine and faeces.
Will I be given the actual medicine for an illness?
No, this is an early study to understand the medicine's behaviour, not to treat any condition. You would need to be healthy to join.
Why do you need urine and faeces samples?
These samples help researchers see exactly how much of the study medicine leaves the body and how quickly that happens.
What does 'C-14' mean?
C-14 refers to a very small, safe marker added to the medicine. It's like a tag that helps researchers track the medicine inside your body.
Who can take part in this study?
Only healthy men aged 18 years or older can participate in this specific study.
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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