A study in healthy men to test how BI 1810631 is taken up in the body when taken with or without food
This study focuses on a new medicine called BI 1810631. Researchers want to understand how it behaves in the body, specifically whether taking it with or without food changes how much of the medicine gets into the bloodstream. This is a very early stage of testing, often called a Phase I study, and it involves healthy adult men. The main goal is to gather important information about the drug's safety and how the body handles it. By doing this, scientists can learn more about how the medicine might work, which is a key step before it can be tested in people with specific illnesses. Your participation helps advance medical science.
At a glance
What is this study about?
This study is designed to explore a new potential medicine known as BI 1810631. The main aim is to understand how your body handles this drug. Specifically, we want to see if taking the medicine with a meal changes how much of it gets absorbed into your bloodstream and how quickly. This is really important because for many medicines, food can make a big difference – sometimes helping the medicine work better, and sometimes making it less effective or even causing side effects.
This kind of study is called 'Human Pharmacology' or 'Phase I'. It's one of the very first times a new medicine is given to people. The focus isn't on treating a specific disease, because the people taking part are healthy. Instead, it's about checking how safe the medicine is and carefully tracking how the body processes it. This information is vital for deciding if the medicine should be developed further.
By taking part, you would be helping researchers gather essential details about BI 1810631. This foundational information is crucial for future steps in drug development. It helps scientists understand how to dose the medicine properly and what to expect when it's eventually given to people who might benefit from it. Your contribution plays a key role in advancing medical knowledge and potentially helping others in the future.
Key takeaways
- This is an early study for a new medicine called BI 1810631.
- It aims to see how your body handles the medicine, especially with or without food.
- Only healthy adult men aged 18 and over can participate.
- Your health will be carefully checked and monitored.
- Taking part helps advance medical science for future treatments.
Who may be eligible?
This study is looking for volunteers who are healthy men. You must be at least 18 years old to take part; there's no upper age limit, meaning older men can also participate if they meet all other health checks.
To be considered, you'll go through a series of health checks to make sure you are in good general health. This helps ensure your safety during the study. The medical team will check things like your medical history, do a physical examination, and take blood and urine samples.
If you have any serious health conditions, are taking certain medications, or have other specific health factors, you might not be able to join. The research team will explain all the requirements in detail to make sure the study is suitable and safe for you.
- Are you a man?
- Are you 18 years old or older?
- Are you generally healthy?
- Are you willing to attend regular clinic visits?
- Are you able to follow study instructions carefully?
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 would start with a screening visit. This is where the research team will check your health to make sure you're a good fit for the study. If you qualify, you'll then be asked to attend specific study visits at the research clinic. During these visits, you will receive the study medicine, sometimes with food, and sometimes without, according to the study plan.
Throughout the study, the team will regularly monitor your health. This might involve blood tests, urine tests, checking your blood pressure and heart rate, and asking you about how you're feeling. They will observe how your body reacts to the medicine and if there are any side effects. You will need to attend follow-up appointments after you've taken the medicine to ensure you are well. The total duration of your participation will be fully explained before you agree to join.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is BI 1810631?
It's a new medicine that is being tested for the very first time in people. Researchers want to understand how it behaves in the body.
Why is it important to know if food makes a difference?
For many medicines, food can change how much of it gets into your body and how quickly it works. This study helps doctors know the best way to take this new medicine.
Will this medicine treat any illness I have?
No, this study is not designed to treat any medical condition. It's an early safety and 'how it works in the body' study for healthy volunteers.
Do I have to stay overnight at the clinic?
The study team will explain all the visit requirements, including whether any overnight stays are needed, during the screening process.
Will I be paid for taking part?
Many healthy volunteer studies offer payment for your time and inconvenience. This will be fully discussed with you before you agree to take part.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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