Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy men to test whether food influences the amount of BI 3731579 in the blood

This research study is looking for healthy men to take part. The main goal is to find out if eating food affects how a new medicine, named BI 3731579, is absorbed into the bloodstream. This kind of study is called a 'Phase I' trial in medical research. It’s one of the first steps to understand how a new medicine works in people. Researchers want to see if the medicine behaves differently when taken with food compared to when taken without. This information is very important for deciding how patients might take the medicine in the future. By taking part, you would be helping medical science learn more about new potential treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

27 Jan 2025

Healthy volunteer trial

What is this study about?

Imagine a new medicine that could help people with a health problem. Before it can be used widely, doctors and scientists need to understand exactly how it works in the body. This particular study is one of the very first steps in that journey. It's called a 'Phase I' study, which means it's about understanding the basics of a new medicine in a small group of healthy people, rather than treating a specific illness.

The main question this study wants to answer is quite simple: does food affect how a new medicine called BI 3731579 gets into your bloodstream? Sometimes, medicines are absorbed differently if you've recently eaten, which can change how well they work or if they cause side effects. By testing the medicine with and without food, researchers can figure out the best way for people to take it in the future.

Taking part in this study means you would be helping science move forward. The information gathered here is vital for researchers to decide on the best dosage and timing for this new medicine, paving the way for it to potentially help patients in much later stages of research. It's an important step in developing new treatments.

Key takeaways

Study for healthy men aged 18 and over.
Investigates if food affects a new medicine (BI 3731579) in the bloodstream.
This is an early-stage 'Phase I' study.
Participation involves health checks, medicine doses, and blood tests.
Aims to gather important information for future medicine development.
You can withdraw from the study at any time.

Who may be eligible?

This study is specifically for men who are healthy, which means you shouldn't have any major ongoing health problems or illnesses. You'll have a health check to make sure you're suitable.

You need to be at least 18 years old to join this study. There isn't an upper age limit mentioned, but your general health will be a key factor for the researchers.

Because this study is looking at how a new medicine works, there will be strict guidelines about any other medicines you might be taking, or if you have certain health conditions. This is to make sure the results are clear and safe for everyone involved.

Quick self-check

Are you a man?
Are you 18 years old or older?
Are you generally healthy, without any major ongoing medical conditions?
Are you willing to follow specific study instructions regarding food and other medicines?
Are you able to attend all required study appointments?

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 would first go through a screening process. This is like a thorough health check-up to make sure you're healthy enough for the study. If you're suitable, you would then agree to specific study visits.

During these visits, you would likely receive doses of the study medicine, BI 3731579, sometimes with food and sometimes without, to see how your body reacts. Healthcare professionals would regularly take blood samples to measure how much of the medicine is in your system. You might also have regular health checks, like blood pressure, heart rate, and temperature measurements.

Each study phase might involve staying at a clinic for a short period or coming in for regular visits. The total duration of your participation, including follow-up appointments after you've finished taking the medicine, would be explained to you in detail before you agree to anything.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. For this type of early-stage study, the main benefit isn't to you directly, but to medical science, as you'd be helping researchers understand new medicines. There might be some payment for your time and inconvenience. Potential risks could include side effects from the new medicine, which are usually mild but could be more serious, or discomfort from procedures like blood tests. You will be closely monitored by medical staff throughout the study. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual healthcare.

Locations (1)

—
Germany

Common questions

What is the main purpose of this study?

The main purpose is to see if eating food changes how a new medicine, BI 3731579, gets into the blood of healthy men.

Who can take part in this study?

Healthy men aged 18 years or older can take part.

Will this medicine treat a health condition I have?

No, this is an early-stage study in healthy volunteers, not intended to treat any specific illness.

What does 'Phase I' mean in a study?

'Phase I' means it's one of the first studies in people, focusing on safety and how the medicine acts in the body, rather than treating a disease.

Will I be paid for taking part?

It's common for healthy volunteer studies to offer some payment for your time and travel, but this would be confirmed by the study team.