A study in healthy men to test whether BI 1015550 influences the amount of nintedanib and pirfenidone in the blood
This research study is for healthy adult men and is called an early-stage or 'Phase I' trial. The main goal is to see how a new medicine, BI 1015550, might change the levels of two other medicines, nintedanib and pirfenidone, in the blood. Nintedanib and pirfenidone are used to treat certain lung conditions. By understanding how these medicines interact, doctors can make sure future treatments are safe and work well. This type of study is crucial for developing new medicines and making sure they can be used effectively with other treatments. It helps researchers learn important information about how drugs work in the body before they are given to people with illnesses.
At a glance
What is this study about?
This study is a very early step in checking how new medicines work. It's designed for healthy men to understand basic things about a new drug called BI 1015550, and how it might affect two existing medicines, nintedanib and pirfenidone, in the body. Think of it like testing how different ingredients mix together when you're cooking – the researchers want to see if adding BI 1015550 changes how much nintedanib and pirfenidone are present, and for how long, in your bloodstream.
Nintedanib and pirfenidone are medicines currently used to treat serious lung conditions, like pulmonary fibrosis. This early research is important because if someone needs to take BI 1015550 alongside either of these other drugs in the future, doctors need to know if there will be any changes to how those medicines work. For example, will their levels in the blood go up or down? This knowledge helps ensure patient safety and that any future treatments are effective.
By taking part, you would be helping medical science learn vital information. This type of study doesn't aim to treat an illness; instead, it's about gathering foundational knowledge on how drugs behave in the human body. This allows scientists to develop safer and more effective treatments for people who really need them in the future.
Key takeaways
- This is an early-stage study for healthy men.
- It checks how a new drug, BI 1015550, affects existing medicines.
- Participation helps future medical research develop safer treatments.
- It involves taking medicines and having blood tests.
- You must be 18 or older and in good general health.
- You can stop participating at any time.
Who may be eligible?
This study is looking for volunteers who are healthy and male. You need to be at least 18 years old to take part, and there's no upper age limit mentioned, as long as you're in good health.
To be considered healthy, you would generally need to have no long-term illnesses, not be taking regular medication for any conditions, and typically have a healthy lifestyle. The research team will conduct a thorough health check to make sure you are suitable for the study before you can join.
- Are you 18 years old or older?
- Are you male?
- Are you generally healthy, without any long-term medical conditions?
- Are you able to attend several clinic visits?
- Are you willing to take study medications?
- Are you comfortable with having blood samples taken?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, it will involve several visits to a clinic. You will be given the study medication, BI 1015550, and also nintedanib and pirfenidone, at different times. During your visits, the research team will take blood samples regularly to measure the levels of these medicines in your body. They will also carry out other checks, such as measuring your blood pressure and heart rate, to make sure you are well. The total time you would be involved in the study, including all visits and follow-up checks, would be explained to you in detail before you decide to take part.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is the new medicine BI 1015550?
BI 1015550 is a new medicine being studied. This trial aims to understand how it behaves in the body and if it affects other drugs.
What are nintedanib and pirfenidone?
Nintedanib and pirfenidone are existing medicines used to treat severe lung conditions like pulmonary fibrosis.
Why is this study only for men?
Early studies sometimes focus on one sex to simplify the research and understand basic drug interactions before moving on to broader groups.
Will I get any treatment for an illness?
No, this study is for healthy volunteers and is not designed to treat any illness. Its purpose is to gather information about how medicines interact.
How long will I need to be involved if I join?
The research team will tell you the exact duration, including all visits and follow-up, before you make a decision.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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