A study in healthy men to test how BI 1291583 is taken up by the body
This study is for healthy men to help scientists understand a new medicine called BI 1291583. It's one of the very first studies of this medicine in people. Researchers want to see how the body takes in the medicine, how it moves around inside, and how it leaves the body. They also need to check if it's safe and what side effects it might have. This type of study, called a 'Phase I' or 'human pharmacology' study, is very important for learning about new medicines before they are given to people who are unwell. You won't be given this medicine to treat a health condition, but your participation helps future patients.
At a glance
What is this study about?
This study is about a new medicine called BI 1291583. Scientists need to understand how this medicine works inside the body. This includes how much of it the body soaks up, how it travels to different parts of the body, what changes it undergoes, and how the body gets rid of it. This information is really important for working out the right dose to give people in the future and to see if it's safe to use.
This is an early-stage study, often called a 'Phase 1' study. It's one of the first times this new medicine is being tested in people. Scientists usually test new medicines in healthy volunteers first to make sure it's reasonably safe and to understand its basic behaviour in the body before giving it to people who are unwell.
By taking part, you would be helping researchers learn important information that could lead to new treatments in the future. You wouldn't be given this medicine to treat an existing medical condition, but your contribution is vital for the development of new medications.
Key takeaways
- This study is testing a new medicine in healthy men.
- It's an early-stage study to learn how the body uses the medicine.
- Participation helps scientists develop future treatments.
- You must be at least 18 years old and generally healthy.
- You will have regular check-ups and tests during the study.
- You can withdraw from the study at any time.
Who may be eligible?
This study is specifically looking for healthy male volunteers. You must be at least 18 years old to take part, and there isn't an upper age limit mentioned, meaning older men can also be considered.
Being 'healthy' for this study means you should not have any significant ongoing medical conditions, and you shouldn't be taking any regular medications that could interfere with the study medicine. The research team will do a thorough health check to make sure you are suitable.
- Are you a man?
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Do you not have any major ongoing medical conditions?
- Are you not regularly taking other 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 take part in this study, you will be given the study medicine, BI 1291583. The study team will explain exactly how it will be given. You will need to attend several appointments at the study clinic, and throughout the study, you'll have various tests like blood samples, urine tests, and possibly other checks to see how your body is reacting to the medicine. The total length of your participation, including the time you are taking the medicine and any follow-up checks, will be fully explained by the study team before you decide to join.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is BI 1291583?
It's a new medicine being tested for the first time in people to understand how it works in the body and if it's safe.
Why are only healthy men being asked to join?
This is an early-stage study, and often new medicines are first tested in healthy volunteers to see how they behave in the body without other illnesses getting in the way.
Will this medicine treat any illness I have?
No, this study is not for treating an illness. You must be healthy to join.
What kind of tests will I have?
You can expect to have blood tests, urine tests, and other health checks to see how your body reacts to the medicine.
Can I stop taking part if I change my mind?
Yes, you can leave the study at any time, for any reason, and your regular medical care won't be affected.
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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