Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy men to test how BI 1569912 is processed in the body

This research study is looking for healthy men to help scientists understand how a new medicine, called BI 1569912, is handled by the body. This is a very early study, often called a Phase 1 or human pharmacology study. Its main purpose is to see how the medicine is absorbed, how it changes, and how it's eventually removed from the body. By learning these things in healthy people, researchers can gather important information about the medicine before it's tested in people with specific illnesses. Your participation would help build a foundation of knowledge for potentially developing new treatments in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

20 Aug 2024

Healthy volunteer trial

What is this study about?

Imagine a new medicine that doctors hope will help people. Before it can be used widely, scientists need to understand exactly what happens to it once it's inside the body. This study, called "A study in healthy men to test how BI 1569912 is processed in the body," is designed to do just that.

In simple terms, researchers want to see how this new investigational medicine, BI 1569912, moves through the body. They'll be looking at how much of it gets absorbed, how the body might change it, and how quickly it's removed from your system. This process is often called "human pharmacology."

This type of study is really important because it's one of the first steps in testing a new medicine in people. By understanding how the medicine behaves in healthy men, scientists can get vital clues about how it might work, and what dose might be safe, for future studies in people who might actually need the medicine for a health condition. It helps lay the groundwork for potentially developing new and effective treatments down the line.

Key takeaways

This study is for healthy men aged 18 and over.
It aims to understand how a new investigational medicine (BI 1569912) moves through the body.
It's an early-stage (Phase I) study to gather important safety and processing information.
Participation involves health checks, taking the medicine, and providing blood/urine samples over time.
You'll be helping medical science for potential future treatments.
You have the right to withdraw from the study at any point.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You'd need to be at least 18 years old to take part, and there's no upper age limit mentioned.

Being a 'healthy volunteer' means that you generally don't have any significant ongoing medical conditions that could affect how the study medicine works in your body, or that could make participating in the study unsafe for you. You would have a health check to confirm you meet these criteria.

Because this study is focused on how the medicine is processed in men, only men can take part.

Quick self-check

Are you male?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you willing to undergo medical check-ups and provide samples?
Are you able to attend study visits as required?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you choose to take part, you would likely have an initial screening visit to check your overall health and make sure you meet all the study requirements. This would involve a physical exam, blood tests, and perhaps other checks. If eligible, you would receive the study medicine, BI 1569912.

The study would involve several visits to a clinic or research centre. During these visits, researchers would take samples of your blood, and possibly urine, at various times after you take the medicine. This helps them track how the medicine is moving through and being processed by your body. You might also have other assessments to monitor your health.

The total duration of your participation, including the number of visits and any follow-up, would be fully explained to you before you agree to join. Some Phase I studies involve overnight stays, but this would be detailed in the full study information.

Potential risks and benefits

The main benefit of taking part in this early-stage study is contributing to medical science and helping to develop potential new medicines that could benefit others in the future. As with any medicine, there's always a possibility of experiencing side effects, which could range from mild to more serious. The study team will carefully monitor you for any effects and will explain all known or potential risks to you. You have the fundamental right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What does 'healthy volunteer' mean?

It means you generally don't have any major health problems and are in good physical condition, as confirmed by a doctor during screening.

Why can only men take part in this study?

Some medicines can behave differently in men and women, so researchers sometimes focus on one gender at a time in early studies to get clear data.

What is a 'Phase I' study?

It's one of the first times a new medicine is tested in humans, usually to check safety and how the body handles the medicine, rather than to treat a disease.

Will I be paid to participate?

Sometimes studies offer payment for your time and inconvenience, but this varies. You should ask the study team if this is the case.

What is BI 1569912?

It's the name of the investigational medicine being tested. It doesn't have a common name yet, as it's still in early development.