Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study in healthy men to find out how different doses of BI 3009947 are tolerated and how different formulations or food influence how BI 3009947 is taken up into the blood

This study is looking for healthy men to help us learn about a new medicine called BI 3009947. It's the very first time this medicine will be given to people. We want to understand how safe it is at different doses and how well your body takes it in. We'll also check if taking it with food, or in slightly different ways, changes how it gets into your bloodstream. This information is important for developing new medicines responsibly and helps us understand how best to use them in the future. Your participation helps medical science advance.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

19 Sep 2025

Healthy volunteer trial

What is this study about?

This study is about a brand-new medicine, BI 3009947, which has never been given to people before. This kind of study is really important because it's the very first step in understanding how a potential new treatment works in the human body. Because we're only looking for healthy volunteers, the main goal is to check for safety and understand how the medicine behaves.

Specifically, researchers want to find out how well healthy men tolerate different amounts (doses) of BI 3009947. They will also look at how the medicine is absorbed into the blood. Sometimes, how a medicine is made (its 'formulation') or whether you take it with food can change how your body takes it in. This study will explore those details to find the best way to give this new medicine in future studies.

By taking part, healthy volunteers help scientists gather crucial information. This data will be used to decide if the medicine is safe enough to be studied in people with specific health conditions later on. It’s an essential part of developing new treatments and making sure they are used effectively and safely.

Key takeaways

This is a study for healthy men only.
It's the first time this new medicine (BI 3009947) will be given to people.
The main goals are to check safety and how the medicine is absorbed.
Your participation helps advance medical research.
Careful monitoring will be provided throughout the study.

Who may be eligible?

To join this study, you must be a healthy man. This means you generally don't have any major ongoing health problems.

You need to be at least 18 years old. There is no upper age limit, so men over 18 can be considered.

Aside from being a healthy man and of the right age, the researchers will check other health details to make sure the study is right for you. They will explain everything clearly during the screening process.

Quick self-check

Are you a man?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Do you not have any major ongoing health conditions?

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'll first have a screening visit to check if you're suitable for the study. This usually involves health checks, a review of your medical history, and some tests. If you qualify, you'll receive the study medicine, BI 3009947, in different doses. You might be asked to stay at the clinic for certain periods, and there will be follow-up appointments and tests to see how the medicine affects you and how it's absorbed into your blood. The total duration of your participation will be explained to you in detail.

Potential risks and benefits

Participating in research always carries some potential risks. Since this is the first time humans are receiving this medicine, there might be side effects that are not yet known. The study team will monitor you closely and explain all known risks. While there are no direct health benefits to you as a healthy volunteer, your participation is invaluable for advancing medical knowledge, which could help others in the future. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What does 'healthy volunteer' mean for this study?

It means you generally don't have any significant ongoing health conditions or take regular medications that could interfere with the study medicine.

Will I receive the new medicine?

Yes, if you qualify and choose to participate, you will receive different doses of the new medicine, BI 3009947.

How long will I need to be involved?

The exact duration will be explained by the study team, but it will involve several visits, potentially some overnight stays, and follow-up checks.

Will I get paid for taking part?

Compensation for your time and travel might be offered; this will be clearly explained by the research team if you are eligible.

What kind of tests will I have?

You might have blood tests, urine tests, heart checks (like an ECG), and physical exams to monitor your health and how the medicine affects you.