A study in healthy men to test whether zongertinib influences the amount of 4 other medicines (dabigatran, rosuvastatin, metformin, and furosemide) in the blood
This research study is trying to understand how a new investigational medicine called zongertinib interacts with several common medications. Specifically, we want to see if zongertinib changes the amount of other medicines (like dabigatran, rosuvastatin, metformin, and furosemide) in a person's bloodstream. This is important because it helps doctors know if zongertinib can be safely given along with these other treatments. The study is open to healthy men aged 18 and over. It's an early-stage study, meaning it's one of the first times this kind of research is being done in people. By taking part, you would help us learn more about how medicines work together.
At a glance
What is this study about?
This study is designed to understand how a new medicine, which we'll call 'zongertinib,' interacts with other commonly used medications. When you take different medicines at the same time, they can sometimes affect how each other works in your body. For example, one medicine might make another medicine stronger or weaker, or it might change how quickly your body gets rid of the other medicine.
In this research, we're focusing on four specific medicines: dabigatran (often used for blood clots), rosuvastatin (for high cholesterol), metformin (for diabetes), and furosemide (a water tablet). We want to see if taking zongertinib at the same time changes the levels of these four medicines in your blood. This is a very important step in developing new medicines, as it helps us understand if zongertinib can be safely used alongside other treatments that people might already be taking.
This kind of study is called a 'pharmacokinetic trial,' which is a scientific way of saying we're studying how the body handles medicines – how they're absorbed, distributed, processed, and removed. It's an early-stage study, meaning it's one of the first times we're testing this in people. The information gathered from participants in this study will help doctors and scientists understand how to use zongertinib safely and effectively in the future.
Key takeaways
- This study is for healthy adult men.
- It checks how a new medicine interacts with common existing medicines.
- Participation involves taking medicines and having blood tests.
- It's an early-stage study to gather important safety information.
- You'll be closely monitored by medical staff.
Who may be eligible?
This study is specifically looking for healthy, adult men to take part. To be eligible, you must be at least 18 years old – there is no upper age limit, as long as you are healthy enough to participate.
To ensure the results are clear and easy to understand, the study is only open to men because sometimes medicines can affect men and women differently. We also want to make sure you are generally healthy, as this helps us understand how the investigational medicine works without other health conditions making the results unclear.
Before you can join, the study team will carry out some checks to make sure this study is right and safe for you. This will involve reviewing your medical history and doing some health tests.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a man?
- Are you 18 years old or older?
- Are you generally healthy?
- Are you willing to attend regular clinic visits?
- Are you comfortable with taking new medicines and having blood tests?
What does participation involve?
If you decide to take part in this study, you would receive the investigational medicine, zongertinib, as well as the other medicines being studied (dabigatran, rosuvastatin, metformin, and furosemide). You would attend several visits to the study clinic. During these visits, the study team would take blood samples to measure the levels of the medicines in your body. You might also have other health checks such as blood pressure measurements or heart rate monitoring.
Some visits may require you to stay at the clinic for a longer period, possibly overnight, to allow for frequent blood sampling. You will be closely monitored by the study staff throughout your participation. The total duration of your involvement in the study, including all visits and follow-up, will be explained in detail before you agree to take part.
Potential risks and benefits
Locations (1)
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Common questions
What is the new medicine, zongertinib, for?
The study isn't testing zongertinib as a treatment for any condition. It's an early study to see how it acts in the body and if it affects other medicines.
Will I receive treatment for a medical condition in this study?
No, this study is not designed to treat any medical conditions. It’s focused on understanding how medicines interact, not on providing therapy.
Why are only men being invited to participate?
Sometimes medicines can work differently in men and women, so to get clear information for this specific research question, we are focusing on healthy men.
What happens if I feel unwell during the study?
The study team will monitor you closely. If you feel unwell at any point, you should tell the staff immediately, and they will provide care and determine the best course of action.
Will I be paid for taking part?
Information about payment or reimbursement for your time and travel will be provided by the study team if you are invited to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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