A study in healthy people to test whether BI 1291583 influences the amount of dabigatran in the body
This research study is for healthy people and aims to understand how a new investigational medicine, called BI 1291583, interacts with a commonly used blood-thinning medication called dabigatran. Dabigatran is often prescribed to help prevent blood clots. The main goal of this particular study is to see if BI 1291583 changes the amount of dabigatran in your body when taken together. This is an early-stage study, meaning it's one of the first times this new medicine is being tested in humans. Studies like this help researchers learn more about how new medicines work and if they are safe before they are given to more people with blood clot conditions.
At a glance
What is this study about?
This study is an early research project, sometimes called a Phase 1 or 'human pharmacology' study. It's designed to learn more about how a new medicine, known as BI 1291583, behaves inside the human body. Specifically, the researchers want to find out if this new medicine has an effect on another drug called dabigatran. Dabigatran is a well-known medication used to thin the blood and help prevent clots.
When we talk about a medicine 'influencing the amount' of another drug, it means scientists want to see if BI 1291583 makes the body absorb more or less dabigatran, or if it changes how quickly dabigatran leaves the body. This information is really important because it helps doctors understand if these two medicines can be safely used together and what the right doses might be.
By understanding how these medicines interact, researchers can make sure that dabigatran works as it should when a person is also taking BI 1291583. This could help prevent potential problems in the future for patients who might need both medicines. This study is a stepping stone in the long process of developing new treatments and ensuring they are safe and effective.
Key takeaways
- This study is for healthy men aged 18 and over.
- It tests how a new medicine interacts with a blood-thinner called dabigatran.
- The aim is to see if the new medicine changes the amount of dabigatran in the body.
- It's an early-stage study (Phase 1) focused on safety and how the drug works.
- Taking part helps medical research and future treatments.
Who may be eligible?
This study is looking for healthy men who are 18 years old or older. Being 'healthy' means you generally don't have any major medical conditions and are not taking regular medicines that might interfere with the study drugs.
The researchers are specifically looking for men, and there isn't an upper age limit mentioned, meaning anyone over 18 years old could be considered if they meet the other health requirements.
Before you can join, a medical team will carefully check your health to make sure this study is safe and suitable for you. They will ask questions about your health, medical history, and current medicines.
- Are you male?
- Are you 18 years old or older?
- Are you generally healthy, without major medical conditions?
- Are you not currently taking other regular medications that could affect the study?
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 will be given the new medicine (BI 1291583) and dabigatran. You will need to make several visits to a clinic over a set period. During these visits, the study team will take blood and urine samples to measure the levels of the medicines in your body. They will also regularly check your health, including your blood pressure and heart rate, to make sure you are doing well. The total length of your participation, including any follow-up checks after you stop taking the medicine, will be explained in full detail by the study team.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What does 'healthy volunteer trial' mean?
It means the study is looking for people who are generally well, without any major health problems, to help test a new medicine safely.
What is dabigatran?
Dabigatran is a medicine that helps thin the blood to prevent clots from forming.
What does a 'Phase 1' study mean?
Phase 1 studies are early research. The main goals are to check if a new medicine is safe and how it works in the body, often for the first time in humans.
Will I receive any treatment for a medical condition?
No, this study is about understanding how medicines interact, not about treating an illness. It's for healthy volunteers.
Do I have to pay to take part?
No, you do not have to pay. Any travel costs or time away from work may be covered by the study, but you should ask the study team about this.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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