A Study in Healthy Male Participants to Compare How CHF10196 Affects How the Body Absorbs and Processes Two Commonly Used Medicines: Dabigatran, a Blood Thinner, and Rosuvastatin, a Medicine Used to Lower Cholesterol
This research study aims to understand how a new medicine, called CHF10196, interacts with two widely used medications: dabigatran, which is a blood thinner, and rosuvastatin, which helps lower cholesterol. We want to see if taking CHF10196 at the same time as these other drugs changes how they are absorbed and processed by the body. This is really important for making sure that medicines are safe and work properly when people need to take more than one. We are looking for healthy men aged 18 to 55 to take part. By understanding these interactions early on, we can help ensure that when CHF10196 is eventually used in patients, it can be combined safely with other essential treatments.
At a glance
What is this study about?
This study is all about understanding how medicines interact with each other. Sometimes, when you take two different drugs at the same time, one can change how the other works in your body. It might make it stronger, weaker, or even cause unexpected side effects. Researchers need to test these interactions very carefully before new medicines become widely available.
In this particular study, we're focusing on a new drug called CHF10196. We want to see if it changes how two common and important medicines are handled by your body: dabigatran, which is a blood thinner often prescribed to prevent clots, and rosuvastatin, which is used to lower high cholesterol. By understanding if CHF10196 affects these drugs, we can make sure that if it's approved for use in the future, doctors will know exactly how to prescribe it safely alongside other medications.
We're inviting healthy men to participate because this allows us to see the effects of the medicines clearly, without other health conditions getting in the way. The information we gather will be vital for ensuring the safety and effectiveness of new treatments for everyone.
Key takeaways
- This study explores how a new drug (CHF10196) might interact with two common medicines.
- It aims to ensure future medicines can be used safely with other treatments.
- Only healthy men aged 18-55 can participate.
- Participation involves taking study drugs, clinic visits, and health monitoring.
- Your health will be closely monitored throughout the study.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be a healthy man between 18 and 55 years old. Your body weight should also be within a healthy range for your height. We're looking for people who don't smoke, or who stopped smoking a long time ago.
It's important that you are generally well, with no major health problems, based on a check-up by our medical team. Your heart rate, blood pressure, and heart tracing (ECG) should all be normal. You also need to be able to understand and follow the study instructions carefully.
There are also some reasons why you wouldn't be able to join. For example, if you're already taking certain other medications, have recently been in another clinical study, or have any significant medical conditions like bleeding disorders or serious infections like HIV or hepatitis. We also can't include anyone with a history of drug or alcohol misuse, or if you've recently had COVID-19.
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 aged between 18 and 55?
- Do you generally feel healthy and well?
- Are you a non-smoker or quit smoking a long time ago?
- Do you have no major health problems or serious infections?
- Are you able to attend all clinic visits and follow instructions?
What does participation involve?
If you join this study, you would receive the study medications (CHF10196, dabigatran, and rosuvastatin) at different times. The research team will regularly check your health through blood tests, urine tests, and monitoring your vital signs (like blood pressure and heart rate). We'll also ask you about how you're feeling and if you have any side effects.
The study involves several visits to the clinic, which might include overnight stays, and follow-up appointments. The exact number of visits and the total length of your participation will be fully explained to you before you agree to take part. You'll need to follow specific instructions about what you can eat and drink, and which other medicines you can take, during certain parts of the study.
Potential risks and benefits
Locations (1)
- Fortrea Clinical Research Unit (CRU) LimitedVerified postcodeLeeds, United Kingdom
Common questions
What is CHF10196?
CHF10196 is a new medicine being studied. We are trying to understand how it behaves in the body and if it affects other common drugs.
Why are you studying dabigatran and rosuvastatin?
These are two commonly used medicines (a blood thinner and a cholesterol-lowering drug). It's important to know if new medicines like CHF10196 can be safely taken alongside them.
Will I get paid for taking part?
Information about any payment or reimbursement for your time and travel will be fully explained to you by the study team.
What happens if I feel unwell during the study?
The study team will monitor you closely, and you can contact them at any time if you feel unwell or have any concerns.
Is this a new treatment for an illness?
No, this is an early-stage study in healthy volunteers to understand how drugs interact, not to treat a specific illness.
How to find out more
Chiesi Clinical Trial Info
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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