A study in healthy people to test whether erythromycin influences the amount of BI 1291583 in the blood.
This research study is for healthy volunteers and aims to investigate how a widely used antibiotic, erythromycin, might affect levels of a new medicine, BI 1291583, in the blood. This type of study, often called a Phase 1 study, is a very early but important step in developing new treatments. By understanding how these medicines interact, scientists can make sure that if BI 1291583 is eventually used as a treatment, it can be given safely alongside other common medications like erythromycin. Your participation helps us learn vital information that contributes to safer healthcare for everyone, without you directly receiving a treatment for a specific illness.
At a glance
What is this study about?
This study is a research project designed for healthy people, not people with a specific illness. Its main goal is to find out if a common antibiotic called erythromycin changes the amount of another medicine, BI 1291583, in your blood. Think of it like this: when you take two different medicines, sometimes one can affect how the other works in your body. We want to see if erythromycin has this kind of effect on BI 1291583.
This is a very early stage of research, often called a 'Phase 1' study. It's not about treating a disease, but about carefully observing how a new medicine behaves in the body. Scientists do these studies to gather important information about how a medicine is absorbed, distributed, processed, and removed from the body. This helps them understand its basic properties before it's ever given to people who are ill.
The reason this matters is that if BI 1291583 is ever used as a treatment in the future, doctors need to know if it can be safely given alongside other common medications, like antibiotics. Your participation in this type of study helps researchers collect crucial information about how medicines interact. This knowledge is essential for making sure that any future treatments are safe and work effectively for patients who need them.
Key takeaways
- This study helps understand how two medicines interact in the body.
- It's for healthy adults (18 years and over).
- Your contribution is vital for future safe medicine use.
- You won't be treated for an illness in this study.
- Participation involves clinic visits and health checks.
- You can stop participating at any time.
Who may be eligible?
This study is looking for healthy adults. You must be at least 18 years old to take part. There is no upper age limit, meaning older adults are also welcome to participate, as long as they meet the health criteria.
Both men and women can join this study. The main requirement is that you feel well and are considered generally healthy by the study doctors. This helps us to see how the medicines behave in a typical, healthy body without other health conditions or medications complicating the results.
The research team will carry out some health checks to make sure it's safe for you to take part. This might include checking your medical history, having a physical exam, and some basic tests. These checks are there to protect your safety and ensure the study results are clear.
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Are you able to visit a clinic for study appointments?
- Are you comfortable having blood samples taken?
- Are you willing to follow specific study instructions?
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 need to attend the study clinic for several visits over a period of time. During these visits, study doctors and nurses will closely monitor your health. You will be given either erythromycin, BI 1291583, or both, according to the study plan. These medicines will be given orally, likely as tablets or capsules.
assessments will include regular blood samples to measure the levels of the medicines in your body. Your vital signs (like blood pressure and heart rate) will also be checked frequently, and you may have general health checks like urine tests or ECGs (heart traces). The total duration of your participation, including all visits and any follow-up, will be explained in detail by the study team. It's designed to be as convenient as possible while ensuring we gather all the necessary information.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is a 'healthy volunteer'?
A healthy volunteer is someone who does not have any significant health problems or illnesses that would affect the study results, and who is taking part to help medical research.
Will I be given treatment for an illness?
No, this study is not looking at a treatment for an illness. It's about understanding how medicines interact in healthy people.
What is erythromycin?
Erythromycin is a common antibiotic medicine used to treat various bacterial infections.
What is BI 1291583?
BI 1291583 is a new medicine that is still in the early stages of development. We are studying how it behaves in the body.
How long will I need to be involved?
The full duration of your involvement will be clearly explained by the study team before you agree to take part. It includes all visits and follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.