Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy men and women to test how BI 3000202 is taken up and processed by the body

This study is an early investigation into a new medicine known as BI 3000202. It involves healthy adult men and women, meaning people who don't have any specific illnesses. The main goal is to understand how the body handles this new medicine. This includes seeing how it's absorbed after being given, how it moves around inside the body, and how the body eventually gets rid of it. These types of studies are really important in the early stages of developing new medicines. They help researchers learn whether a new drug is safe enough to be tested further and how it behaves in people before it's given to patients who might benefit from it. This is a crucial step in bringing new treatments to light.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

12 Dec 2025

Healthy volunteer trial

What is this study about?

This study is about a new medicine called BI 3000202. When a new medicine is developed, scientists need to understand how it works in people. This is an early-stage study, often called a 'Phase I' study. It's one of the very first steps in testing a new drug in humans. For this particular study, they are looking for healthy adult volunteers, which means people who don't have any major medical conditions.

The main aim is to carefully watch what happens to BI 3000202 once it's in the body. Researchers want to find out how well the body takes it in, how it travels through the body, and eventually how the body removes it. This information is vital because it helps us understand if the medicine is absorbed correctly and how long it stays in the system. This helps scientists work out the right dose to use and how often it might need to be given in future studies.

By taking part, healthy volunteers play a really important role. The information gathered helps scientists decide whether this medicine is safe enough and behaves predictably enough to be tested in people with specific illnesses later on. It's a key part of making sure new treatments are developed safely and effectively for everyone.

Key takeaways

This is an early-stage study of a new medicine (BI 3000202).
It aims to understand how the medicine is processed by the body in healthy adults.
Participation involves taking the medicine and having regular health checks.
You must be 18 years or older and in general good health.
No direct personal health benefit is expected, but you contribute to medical science.
You can leave the study at any time, for any reason.

Who may be eligible?

To take part in this study, you need to be a healthy adult. This means you generally don't have any ongoing medical conditions that might affect how your body handles the study medicine or might put you at extra risk.

The study is open to both men and women. You must be at least 18 years old to join, and there's no upper age limit specified, as long as you meet the other health requirements.

Because this study is looking at how a new medicine works in a healthy body, there will be specific checks to make sure you are in good health. These checks might include blood tests, a physical exam, and looking at your medical history to ensure your body is in a suitable condition for the study.

Quick self-check

Are you 18 years old or older?
Are you generally healthy, without significant ongoing medical conditions?
Are you available for regular study visits?
Are you comfortable with blood tests and physical examinations?
Are you happy to follow specific instructions about diet or other medicines?

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 be given the study medicine, BI 3000202. The study team will then closely monitor your body's response. This typically involves several visits to the study clinic, where you might have blood samples taken, your vital signs (like blood pressure and heart rate) checked, and undergo other simple health assessments. You'll likely be asked to follow specific instructions, such as avoiding certain foods or other medicines during the study period. The total duration of your involvement could range from a few days to several weeks, including follow-up appointments to make sure you're well after the medicine has left your system. Details about the exact number of visits, their length, and the overall time commitment will be fully explained before you agree to join.

Potential risks and benefits

Taking part in a study like this might not directly benefit you, as the main goal is to learn about the new medicine in healthy people. However, you would be making a valuable contribution to medical research, helping to advance the development of potential new treatments for others. As with any medicine, there's always a chance of side effects, which could be mild (like a headache) or, very rarely, more serious. The study team will explain all known or expected risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Netherlands

Common questions

What is BI 3000202?

BI 3000202 is a new medicine that is being investigated for the very first time in people. Its specific use isn't the focus of this healthy volunteer study.

Why is this study being done in healthy people?

Studies in healthy people are a crucial first step to understand how a new medicine behaves in the body and to check its safety before it's given to patients who have a specific illness.

Will I have to stay at the clinic?

The study design will explain whether you need to stay overnight at the clinic or if your visits will be during the day. This will be made clear to you before you agree to take part.

Will I get paid for taking part?

Sometimes, studies like this offer payment for your time and inconvenience. This information will be provided by the study team if it applies to this trial.

What if I feel unwell during the study?

The study team will be available to support you and will provide clear instructions on who to contact immediately if you feel unwell or have any concerns during the study.