Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test how well different doses of BI 1584862 are tolerated by healthy men

This study is an early-stage medical trial involving healthy men. Its main purpose is to carefully check a new medicine, known as BI 1584862, at different dose levels. Researchers want to understand how safely the body handles this new medicine and what effects it might have. This type of study, called a Phase 1 trial, is crucial for gathering basic information about a new drug. This helps scientists decide if it's safe to continue testing in the future with people who have specific health problems. We are looking for volunteers aged 18 and over who are healthy men to take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

25 Jul 2023

Healthy volunteer trial

What is this study about?

This study is exploring a new medicine called BI 1584862. It's what we call a 'Phase 1' trial, which means it’s one of the very first times this medicine is being given to people. The main goal at this stage isn't to treat a specific illness, but to understand the medicine itself. We’re particularly interested in finding out how safe it is and how the body handles it at different amounts (doses).

Think of it like testing a car prototype. Before it goes on the road for everyone, engineers first check if the basic parts work safely and reliably. Similarly, in this study, doctors want to see if the medicine is well-tolerated by healthy volunteers before considering if it could help people with certain health conditions later on.

Taking part in this kind of study helps researchers learn vital information that can lead to new and better treatments in the future. By carefully studying BI 1584862 in healthy men, we can ensure we build a strong understanding of its effects, paving the way for further research if it proves promising.

Key takeaways

This is an early study testing a new medicine called BI 1584862.
It's for healthy men, aged 18 and over.
The main goal is to check how safe the medicine is at different doses.
Participation helps scientists learn about new medicines for the future.
You can stop taking part at any time.
All potential risks will be discussed with you.

Who may be eligible?

This study is looking for volunteers who are healthy men. You must be at least 18 years old to take part. There is no upper age limit for this study, as long as you are generally healthy.

'Healthy' generally means you don't have any major ongoing medical conditions that would make it unsafe for you to take part in the study or affect the results. Doctors will carefully check your health to make sure this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you able to attend study visits as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive doses of the study medicine, BI 1584862. You would have regular check-ups and medical tests throughout the study. This would involve visiting the study centre for appointments. These appointments are designed to monitor your health closely and see how your body reacts to the medicine. The full duration of the study, including all visits and follow-ups, would be explained to you in detail before you make any commitment.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. You wouldn't directly benefit from this study, as it's to gather information about a new medicine. However, your participation helps advance medical science, which could lead to new treatments for others in the future. Potential risks might include side effects from the medicine, which could be mild (like a headache) or, very rarely, more serious. All known risks will be fully explained to you. You are free to stop taking part in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Germany

Common questions

What is BI 1584862?

It's a new medicine that is being tested for the first time in people. We want to see how the body handles it and if it's safe.

Why are you only looking for healthy men?

Early studies like this often start with a specific group of healthy volunteers to understand the medicine's basic effects without other health conditions getting in the way.

Will I get paid for taking part?

You should ask the study team about any expenses or payments you might receive for your time and travel if you participate.

What kind of tests will I have?

This could include blood tests, physical exams, and other checks to make sure you are safe and to see how the medicine affects you. All tests will be explained clearly.

How long will the study last if I join?

The full length of your participation, including all visits and follow-ups, will be clearly explained by the research team before you agree to take part.