A study in healthy people to compare two different tablets of BI 685509 and to test how food and esomeprazole influence the amount of BI 685509 in the blood
This research study is looking for healthy volunteers to help us understand a new medicine called BI 685509. We'll be comparing two different tablet forms of this medicine to see if one works better or is absorbed differently. A key part of the study is finding out how food or a common stomach acid medicine (esomeprazole) affects how much BI 685509 gets into your bloodstream. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people. The main goal is to gather important information about how the medicine behaves in the body, which helps us decide if it should be studied further for specific health conditions in the future.
At a glance
What is this study about?
Imagine scientists are creating a new key, BI 685509, to unlock certain processes in the body. Before they can use this key to help people with specific illnesses, they need to understand how the key itself works.
This study is a bit like a "test drive" for this new key. We're inviting healthy people, not those with a particular illness, to help us. We’ll be looking at two slightly different versions of the BI 685509 tablet. We want to see if one tablet delivers the medicine to your body more effectively or differently than the other. This helps us choose the best tablet form for future studies.
Another important question we want to answer is how common things like eating food or taking a medicine for stomach acid (called esomeprazole, which many people take) might change how your body takes in BI 685509. This information is really important because it tells us if people need to take the medicine in a special way, for example, with or without food, to make sure it works as intended. Understanding these early details is a crucial step before we can investigate if BI 685509 can help treat specific health conditions.
Key takeaways
- It's a study for healthy people, not aimed at treating an illness.
- The goal is to understand how a new medicine, BI 685509, works in the body.
- Researchers will compare two tablet forms and see how food or stomach medicine affects it.
- Participation involves clinic visits, blood tests, and possibly overnight stays.
- Your health will be closely monitored, and risks/benefits will be explained.
Who may be eligible?
This study is looking for generally healthy people aged 18 or older to take part. It's open to both men and women.
Because this is an early-stage study, we need participants who don't have any major ongoing health problems. This helps us ensure that any effects we see are from the new medicine, BI 685509, and not from other health conditions or medicines you might be taking.
Specific details about your health, any medicines you currently take, or past medical history will be carefully checked by the study doctor to make sure it's safe and appropriate for you to participate.
- Are you 18 years old or older?
- Are you generally healthy with no major ongoing medical conditions?
- Are you willing to discuss your full medical history with the study team?
- Are you willing to comply with all study procedures, including clinic visits and blood tests?
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 will be given doses of BI 685509, probably orally as tablets. You might also be given food or another medicine called esomeprazole at specific times to see how they affect BI 685509. You will have several visits to the study clinic, and it's likely some of these will involve staying overnight or for longer periods. During these visits, the study team will take blood samples regularly to measure the amount of BI 685509 in your body. They will also perform physical examinations and monitor your vital signs (like blood pressure and heart rate) to check your health and make sure you are tolerating the medicine well. The total length of your participation, including all visits and follow-up, will be explained in detail.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is a 'healthy volunteer' study?
It means the study is looking for people who are generally well and don't have any major health problems. This helps us understand how the new medicine works in a typical body.
What is BI 685509?
It's a new medicine being developed. In this study, we're not testing it for a specific illness yet, but trying to understand how it behaves in the body.
What is esomeprazole?
Esomeprazole is a common medicine many people take to reduce stomach acid. We're testing if it changes how your body handles BI 685509.
Will I receive treatment for an illness?
No, this study is not designed to treat an illness. It's about gathering information on how a new medicine works in healthy people.
Will I get paid for taking part?
Details about any compensation for your time and inconvenience will be fully explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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