A study in healthy men to test how itraconazole influences the amount of BI 764198 in the blood
This study is for healthy adult men and is designed to find out how a well-known anti-fungal medicine, itraconazole, affects the amount of a new study medicine, BI 764198, in the body. When people need to take more than one medicine, it's important for doctors and scientists to understand how these different drugs might interact with each other. This is especially true for new medicines. By studying healthy volunteers, researchers can carefully observe these interactions to make sure treatments are safe and work as expected. This type of research helps doctors decide the best way to prescribe medicines in the future, ensuring patients get the correct dose and avoid unexpected side effects.
At a glance
What is this study about?
This research study is about understanding how different medicines interact in the body. Specifically, it's looking at how a common anti-fungal medicine called itraconazole affects the levels of another medicine, BI 764198, in healthy men. Think of your body as a processing plant for medicines. When you take a medicine, your body absorbs it, uses it, and then gets rid of it. Sometimes, taking one medicine can change how your body handles another medicine.
Itraconazole is a medicine often prescribed to treat fungal infections. BI 764198 is a medicine being studied, which means it's still in the early stages of development. It's really important for scientists to know if taking itraconazole at the same time as BI 764198 changes how much BI 764198 stays in your bloodstream, or how quickly your body processes it.
By carefully studying this interaction in healthy volunteers, researchers can gather important information. This helps them work out the right doses for these medicines if they are ever prescribed together in the future. It's all about making sure medicines are safe and effective for everyone, and this early stage research is a vital step in that process.
Key takeaways
- This study helps understand how two medicines interact in the body.
- It's for healthy adult men, aged 18 and over.
- Researchers will check how an anti-fungal medicine affects a new experimental drug.
- Participation involves medical checks and blood samples.
- This early research is important for future medicine safety and development.
- You won't directly benefit, but you'll help advance medical knowledge.
Who may be eligible?
This study is specifically looking for healthy adult men. You need to be at least 18 years old to take part, and there's no upper age limit, as long as you are considered healthy by the study doctor.
To be considered 'healthy' for this type of research, you'll have a medical check-up. This check-up will ensure you don't have any significant ongoing health problems or illnesses that could affect the study results or make it unsafe for you to take part.
Because this study is looking at how medicines interact in men, women are not eligible to participate. You also won't be able to join if you are already taking certain medications or have specific health conditions, as these could interfere with the study's findings.
- Are you a man?
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Are you able to attend study visits as required?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
The detailed steps for taking part aren't fully described here, but generally, in studies like this, you would have an initial screening visit. This involves a medical examination, blood and urine tests, and a review of your health history to make sure you're suitable. If you qualify, you would then attend a series of visits to the study clinic.
During these visits, you would be given the study medicines (itraconazole and BI 764198) as instructed. Doctors and nurses would regularly take blood samples to measure the levels of the medicines in your body. You might also have other checks, such as blood pressure and heart rate monitoring. The total duration of your involvement, including all visits and follow-ups, would be explained to you before you agree to take part.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is itraconazole?
Itraconazole is a medicine commonly used to treat fungal infections in different parts of the body.
What is BI 764198?
BI 764198 is an investigational medicine, meaning it's still being studied to see if it's safe and effective for its intended purpose.
Why are only men being studied?
Some studies focus on a specific sex to understand how medicines affect them, to limit variables, or because of how the medicine might work in the body.
Is this a new medicine that will cure my illness?
This study is not about finding a cure, but understanding how two medicines interact. BI 764198 is an experimental medicine, still in early development.
Will I get paid to take part?
Information about payment for participation is usually provided by the study team. You should ask them directly about this.
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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