A study in healthy people to test how itraconazole influences the amount of BI 3031185 in the blood
This study is for healthy volunteers and aims to understand how a widely used anti-fungal drug, itraconazole, interacts with a new investigational medicine called BI 3031185. Researchers want to see if itraconazole changes how much BI 3031185 is in the blood. This kind of research is important because medicines can affect each other, and understanding these interactions helps doctors know how to safely prescribe them. By taking part, healthy men will help scientists learn more about how these medicines work together in the human body, which is a crucial step in developing new treatments.
At a glance
What is this study about?
This study is a very early stage of research, often called a Phase I trial. It's designed for healthy people, not those with a specific illness. The main goal is to look at how two medicines act together in the body. One medicine is called itraconazole, which is a common treatment for fungal infections. The other is a new medicine, still in development, referred to as BI 3031185.
The researchers want to see if taking itraconazole changes the amount of BI 3031185 in a person's blood. When two medicines are taken at the same time, they can sometimes affect how each other works. One medicine might make the other stronger, weaker, or stay in the body for a shorter or longer time. Understanding these interactions is a vital part of developing new medicines.
By taking part in this study, you would be helping scientists gather important information about how these medicines behave in humans. This knowledge is essential for making sure that any new medicine, like BI 3031185, can be used safely and effectively in the future, especially if patients might also need to take other common medicines like itraconazole.
Key takeaways
- It's a study for healthy men to understand how medicines interact.
- Researchers are looking at itraconazole (anti-fungal) and a new medicine (BI 3031185).
- It helps ensure new medicines can be used safely alongside others.
- Participation involves taking medicines and attending clinic visits for checks.
- Your contribution directly helps medical research.
Who may be eligible?
To be part of this study, you must be a healthy man, aged 18 years or older. This study is specifically looking for people who are in good general health, as confirmed by medical checks.
Because this is a very early study and specifically looks at how medicines interact, a doctor or nurse will check your health carefully to make sure it's safe for you to take part. They will ask about your medical history and might do some tests.
- Are you a man?
- Are you 18 years old or older?
- Are you generally in good health?
- Are you able to commit to clinic visits and taking study medicines?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
The details of what taking part involves are not fully described in the summary, but typically, this type of study involves several visits to a clinic. You would take the study medicines as instructed. Blood samples would be taken regularly to measure the levels of the medicines in your body. You will likely have health checks, such as blood pressure and heart rate measurements, at each visit. The total duration of your involvement could range from a few days to a few weeks, possibly including an overnight stay at a clinic. You would be given clear instructions on when and how to take the medicines and when your appointments are.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is the main goal of this study?
The main goal is to see how a common anti-fungal medicine (itraconazole) affects the levels of a new medicine (BI 3031185) in the blood when taken together.
Who can take part in this study?
Only healthy men aged 18 years and older can take part.
What will I have to do if I join?
You will take the study medicines and attend clinic visits for health checks and blood samples over a period of time.
Will this study help me with an illness?
No, this study is for healthy volunteers and is not designed to treat an illness, but it helps gather important information for future medicines.
Can I stop being part of the study once I start?
Yes, you can choose to leave the study at any time, and you don't need to give a reason.
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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