A study in healthy men to test whether carbamazepine influences the amount of nerandomilast in the blood
This research is a Phase I study, which means it's an early-stage test in healthy people. Specifically, scientists want to see if a widely used epilepsy medicine, carbamazepine, affects how much of a new drug called nerandomilast gets into the bloodstream and how long it stays there. This is important because medicines can interact with each other in complex ways. Understanding these interactions early helps ensure that new treatments can be safely and effectively prescribed alongside existing medications. The study will involve healthy male volunteers aged 18 and over.
At a glance
What is this study about?
Imagine you're taking two different medicines — how do you know they'll work well together, or if one might change how the other one acts in your body? That's what this study aims to find out. Researchers are testing a new medicine, called nerandomilast, and seeing what happens when it's taken at the same time as carbamazepine, a medicine often used to treat conditions like epilepsy.
The main goal is to understand if carbamazepine affects how much nerandomilast is absorbed into your blood and how quickly your body gets rid of it. This is a very important step in developing new medicines, as it helps doctors know how to safely prescribe them with other drugs you might be taking.
This type of study is called a 'Phase I' trial. This means it's one of the first times the new medicine is being tested in people, specifically in healthy volunteers. It's a foundational step to gather crucial information about how the new drug behaves in the human body before it can be tested in patients who have a particular illness.
Key takeaways
- This study looks at how two medicines interact in healthy men.
- It's an early-stage trial (Phase I) for a new drug called nerandomilast.
- Researchers want to see if carbamazepine changes nerandomilast levels in the blood.
- Understanding drug interactions is key for safe new treatments.
- Participation involves taking medicines and giving blood samples.
Who may be eligible?
This study is looking for healthy men to take part. To be considered, you need to be at least 18 years old – there's no upper age limit, as long as you are healthy.
Because this is an early-stage study, participants need to be in good general health. This helps the researchers understand the new medicine's effects without other health conditions making it complicated.
Only men are being invited to join this particular study. This is common in early drug development, as sometimes drugs behave differently in men and women, and researchers might study one group first.
- Are you a man?
- Are you 18 years old or older?
- Are you generally in good health?
- Are you available for multiple clinic visits?
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 be asked to visit the study clinic multiple times. During these visits, the research team would give you the study medicines (nerandomilast and carbamazepine). You would have blood samples taken regularly to measure the levels of the study drug in your body. There might also be other checks, like blood pressure and heart rate measurements, to make sure you're doing well. The total duration of your involvement could include a screening visit, several dosing visits, and follow-up appointments.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is carbamazepine?
Carbamazepine is a medicine commonly used to treat epilepsy and some types of nerve pain.
What is nerandomilast?
Nerandomilast is a new medicine that is currently being investigated in clinical trials.
Why are only men included in this study?
Sometimes, new drugs are first tested in either men or women to understand basic effects, before being studied more broadly.
What does 'Phase I' mean?
Phase I trials are early-stage studies, usually in healthy volunteers, to see how a new drug acts in the body and if it's safe.
Will I receive any payment for participating?
Clinical trials sometimes offer payment for time and travel. This would be 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.
Discussion
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