A study in healthy people to test whether BI 3000202 affects how 2 other medicines (rosuvastatin and digoxin) are taken up in the body
This important study is for healthy people and is designed to understand how a new medicine, called BI 3000202, interacts with two other widely used medicines: rosuvastatin, which helps manage cholesterol, and digoxin, which is used for certain heart conditions. Researchers want to see if BI 3000202 changes how your body takes in or uses these existing medicines. This is a very early stage of testing, often called a Phase 1 or 'Human Pharmacology' study. It's a key step in developing new medicines safely and ensuring they work well with other treatments you might be taking. Your involvement as a healthy volunteer would help us learn vital information about how medicines work together.
At a glance
What is this study about?
This research study is designed for healthy volunteers and focuses on understanding how different medicines work together in the body. Specifically, we're looking at a new medicine called BI 3000202. The main goal is to see if taking BI 3000202 at the same time as two other well-known medicines – rosuvastatin (often used for high cholesterol) and digoxin (used for some heart conditions) – changes how your body absorbs or processes them.
Learning how medicines interact is really important. Sometimes, taking two medicines together can change how effective they are, or even increase or decrease their side effects. By studying these interactions early on, researchers can make sure that new medicines being developed are safe and can be used effectively alongside other treatments people might need.
This kind of study is called a 'human pharmacology' study, which is often the first time a new medicine is given to people. It's a crucial step in medicine development, helping us understand the basic effects of a new drug and how it behaves when combined with other common medications. Your participation helps us gather this vital information to make future medicines safer and more effective for everyone.
Key takeaways
- This study is for healthy volunteers aged 18 and over, both men and women.
- It aims to understand how a new medicine interacts with common cholesterol and heart medicines.
- You would receive careful medical monitoring throughout your participation.
- Your involvement helps improve the safety and effectiveness of future medicines.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for volunteers who are generally healthy. This means you shouldn't have any major ongoing health conditions or be taking medicines that could interfere with the study.
To be considered, you need to be at least 18 years old. There is no upper age limit, so adults of all ages are welcome to inquire. Both men and women can take part in this study.
Before you can join, the study team will carefully check your health to make sure it's safe for you to participate and that you meet all the specific requirements of the study.
- Are you at least 18 years old?
- Do you consider yourself generally healthy?
- Are you able to commit to several visits to a study clinic?
- Are you comfortable with blood tests and medical check-ups?
- Are you willing to potentially stay overnight at a clinic occasionally?
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 considered a healthy volunteer. This means you will undergo a careful health check to ensure you are suitable for the study. You will likely need to visit the study clinic multiple times, probably over several weeks. During these visits, you'll receive the study medicine, BI 3000202, and also controlled doses of rosuvastatin and digoxin. You may be asked to stay overnight at the clinic for some periods, especially during the times when we are measuring how the medicines are absorbed.
The study team will take blood samples regularly to measure the levels of the medicines in your body. You might also have other tests, like blood pressure checks and heart rhythm (ECG) recordings, to monitor your health. You'll have follow-up appointments after you've finished taking the medicines to make sure you're feeling well. The total duration of your involvement, from your first visit to your final check-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is the new medicine BI 3000202?
It's a new medicine being developed. In this study, we're not testing it for a specific illness; we're just seeing how it behaves in the body and if it changes how other common medicines work.
What are rosuvastatin and digoxin?
Rosuvastatin is a medicine often used to lower high cholesterol. Digoxin is a medicine used to help with certain heart conditions.
Why do you need healthy people for this study?
Using healthy volunteers helps researchers understand the basic effects of the medicine and its interactions without other illnesses complicating the results. This is a common first step in drug development.
Will I be paid for participating?
It's common for healthy volunteer studies to offer compensation for your time and travel, but this would need to be confirmed by the study site.
How long will my participation last?
The study team will explain the exact duration, including how many visits are needed and if there are any overnight stays.
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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