A study in healthy men to test whether esomeprazole influences the amount of BI 3000202 in the blood
This research study is inviting healthy men, aged 18 and older, to take part. The main aim is to understand how a new medicine, called BI 3000202, behaves in the body when it's taken at the same time as esomeprazole. Esomeprazole is a medicine often used to reduce stomach acid, similar to omeprazole. Scientists want to see if taking esomeprazole affects the amount of BI 3000202 that ends up in your blood. This is an early-stage study, called 'Phase I', which usually involves a small number of healthy volunteers. These studies are important for learning how new medicines are processed by the body before they are tested in people who are unwell. Participation is voluntary, and you'll receive full information before deciding if you want to join.
At a glance
What is this study about?
This study is a research project designed to understand how a new medicine, called BI 3000202, behaves in the human body. Specifically, the researchers want to know if taking this new medicine at the same time as another common medicine, esomeprazole, changes how much of it gets into your blood.
Esomeprazole is a medicine that many people take to help with stomach problems, like heartburn or indigestion, as it works by reducing stomach acid. Understanding how two medicines interact is really important. Sometimes one medicine can affect how another medicine is absorbed or broken down in the body.
This kind of study is called a 'Phase I' or 'human pharmacology' study. These are very early-stage studies, and they are usually done with healthy volunteers. The main goal isn't to treat an illness, but to understand basic things about a new medicine, such as how safe it is, how it's handled by the body, and what doses might be suitable for future research. The information gathered from studies like this helps scientists decide if a new medicine is ready to be tested in people who have specific health conditions.
Key takeaways
- This study is for healthy men, aged 18 and older.
- It aims to see how two medicines, BI 3000202 and esomeprazole, interact in the body.
- It's an early-stage study to gather basic information about a new medicine.
- Participation involves clinic visits, health checks, and taking study medicines.
- There are no direct health benefits for participants, but it helps medical research.
Who may be eligible?
This study is specifically looking for healthy male volunteers. You need to be at least 18 years old, and there isn't an upper age limit mentioned, as long as you meet the other health criteria. Being 'healthy' means that you don't have any significant medical conditions that could affect the study results or your safety.
Before you can join, the research team will do a thorough health check-up. This will involve an examination, looking at your medical history, and possibly some blood tests to make sure you are fit and well enough to take part. They need to be sure that your current health status won't be affected by the study medicines or procedures, and that the results they get from you will be reliable and accurate.
- Are you a man?
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Do you not have any major ongoing medical conditions?
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'll need to attend the study clinic for several visits. This will involve physical examinations, providing blood and urine samples, and having your vital signs (like blood pressure and heart rate) checked regularly. You will be given doses of the study medicines, BI 3000202 and esomeprazole, possibly at different times or combinations, as directed by the study team. There will be careful monitoring throughout your participation. The exact number of visits, the total duration of the study, and any follow-up appointments will be fully explained to you before you agree to participate.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is esomeprazole?
Esomeprazole is a common medicine used to reduce stomach acid, often prescribed for heartburn or indigestion.
What is BI 3000202?
BI 3000202 is a new medicine being investigated. This study is an early step to understand how it works in the body.
Will I get paid for taking part?
Information about payment or reimbursement for your time and travel will be provided by the study team if it's available.
Is this a new treatment for an illness?
No, this is a very early study in healthy volunteers, not a treatment for an illness. It's about understanding how medicines behave.
How long will the study last for me?
The exact duration of your involvement, including visits and follow-up, will be clearly explained by the research 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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