A phase I, open-label trial in two parallel parts to investigate mass balance, metabolism, and basic pharmacokinetics of BI 1810631 (C-14) administered as oral solution (part A) and to investigate absolute bioavailability of BI 1810631 administered as film-coated tablet together with an intravenous microtracer dose of BI 1810631 (C-14) (part B) in healthy male volunteers
This study is for healthy men and explores a new medicine called BI 1810631. It has two main parts. Part A investigates how the body breaks down and gets rid of the medicine when taken as a liquid. This helps researchers understand how much of the medicine leaves the body through urine and faeces. Part B focuses on how much of the medicine actually gets into the bloodstream when taken as a tablet, compared to when a tiny, invisible amount is given directly into the blood. This helps doctors work out the best way to give the medicine in the future.
At a glance
What is this study about?
Imagine you take a new medicine. This study is all about understanding what happens to that medicine inside your body. It's called a 'Phase I' study, which means it's one of the very first times this medicine is being tested in people. The main goal is not to treat a specific illness yet, but to learn how the medicine acts in healthy people.
The study has two main parts. In Part A, we're looking at how the body processes the medicine when it's given as a liquid. Scientists will check how much of the medicine and its related substances leave the body through urine and faeces. This is like tracking how much a coloured drink you swallowed comes out later – it helps us see how much is absorbed and how much is just passed through.
In Part B, the focus shifts to how the medicine works when taken as a tablet. Researchers want to know how much of the medicine from a tablet actually gets into your bloodstream. To do this, they'll give you a normal tablet and also a tiny, safe amount of the medicine directly into your blood. By comparing the two, they can figure out how effectively the tablet delivers the medicine. All this information is really important for doctors to decide the best way to give the medicine in the future and to understand its effects.
Key takeaways
- This is an early study in healthy men, aged 18 and over.
- It tests how a new medicine, BI 1810631, moves through and leaves the body.
- Researchers will compare liquid and tablet forms of the medicine.
- You'll provide blood and urine samples for analysis.
- The study helps doctors understand the best way to give this medicine in the future.
Who may be eligible?
This study is looking for healthy male volunteers. You need to be at least 18 years old to take part. There isn't an upper age limit mentioned, but you'll need to be in good general health.
Before joining, you'll have a health check-up to make sure this study is safe for you. This often includes things like blood tests, checking your heart, and making sure you don't have any serious ongoing medical conditions.
The research team will provide full details if you are interested. It's important to discuss any health concerns you have with them.
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 male?
- Are you 18 years old or older?
- Are you generally healthy and don't have any major medical conditions?
- Are you comfortable committing to clinic visits and providing samples?
What does participation involve?
If you decide to take part, you'll be giving different forms of the medicine. In Part A, you'll receive the medicine as a liquid. In Part B, you'll take the medicine as a tablet, and also receive a tiny, safe amount directly into your vein. Throughout the study, the research team will take blood and urine samples regularly to see how the medicine is moving through your body and how it's being cleared.
You'll likely need to spend some time at the clinic for these measurements. This might include an overnight stay or several visits over a period. There will be initial health checks, regular tests during the study, and possibly follow-up appointments after you've finished taking the medicine. The total exact duration will be explained by the study team, but these types of early studies usually involve a commitment of several weeks from start to finish.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is BI 1810631?
It's a new medicine that is being tested for the first time in people to see how it works in the body.
Why do you need healthy volunteers?
By studying healthy people, researchers can understand the basic effects of the medicine without other health conditions making things complicated.
What is the difference between a liquid and a tablet in this study?
The study looks at how the body handles the medicine when given as a liquid versus as a tablet, to find the best way to give it in the future.
Will I get paid for taking part?
This is a common question. Research studies sometimes offer payment for your time and inconvenience. This will be discussed with you by the study team.
Is my health data kept private?
Yes, all personal and health information collected during the study is kept strictly confidential according to privacy laws.
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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