Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy people to test how well different doses of BI 3000202 are tolerated and how they affect the way the body handles midazolam

This early-stage study is for healthy volunteers to help us learn about a new medicine called BI 3000202. We want to find out how safe it is, what are the best doses, and how well people tolerate it. We're also checking how this new medicine might affect the way your body processes another common medicine called midazolam, which is sometimes used for relaxation or before medical procedures. This kind of study is important to make sure new medicines are safe and to understand how they work in the body before potentially being tested in people with specific illnesses. Your participation helps us gather vital information. This is one of the very first studies involving this new medicine in humans.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

18 Mar 2024

Healthy volunteer trial

What is this study about?

This study is a very early step in testing a new medicine called BI 3000202. Think of it like a first road-test for a new car – we want to make sure it runs safely and understand how it works.

The main goals are to see if BI 3000202 is safe for people to take, what doses are well-tolerated (meaning they don't cause too many side effects), and how the body handles it. We'll also investigate if BI 3000202 changes how your body deals with another medicine called midazolam. Midazolam is a commonly used medicine that can make you feel sleepy or relaxed, often given before operations or medical tests.

Understanding how a new medicine affects other drugs is very important. It helps doctors know if it can be given safely alongside other treatments in the future. By participating, healthy volunteers play a crucial role in bringing new and safe medicines to people who might need them one day.

Key takeaways

This is an early study for a new medicine called BI 3000202.
It's for healthy adult volunteers, aged 18 and over.
The main aim is to check if the new medicine is safe and well-tolerated.
It also looks at how BI 3000202 affects how your body handles midazolam.
Your participation helps advance medical research.

Who may be eligible?

This study is looking for healthy adults. You must be at least 18 years old. There is no upper age limit, meaning older adults can also take part if they are otherwise healthy.

To be considered healthy, you would generally not have any serious long-term medical conditions, or be taking regular medicines that could interfere with the study. The study team will conduct health checks to confirm you are suitable.

Anyone, regardless of their gender, can participate in this study. The medical team will discuss your full health history with you to ensure it's safe for you to take part.

Quick self-check

Are you 18 years old or older?
Do you consider yourself generally healthy?
Do you have any serious ongoing medical conditions?
Are you willing to follow study instructions and attend 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 receive the study medicine, BI 3000202. You would also temporarily receive a dose of midazolam to help researchers understand how the two medicines interact. You'd have regular check-ups with the study doctors and nurses, which would involve appointments at the clinic. These appointments might include blood tests, checking your blood pressure and heart rate, and discussing any side effects you might experience. The total duration of your participation, including all visits and follow-up, will be clearly explained by the study team before you agree to join.

Potential risks and benefits

The potential benefits of taking part in this early study include contributing to medical science and helping to develop new treatments that could benefit many people in the future. As with any medicine, there are potential risks, such as side effects from BI 3000202 or midazolam. The study staff will explain all known and potential risks in detail, and you'll be closely monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Belgium

Common questions

What does 'healthy volunteer trial' mean?

It means the study is looking for people who are generally well and don't have any major health problems. This helps us understand how the new medicine works in a typical, healthy body.

What is midazolam?

Midazolam is a medicine that can help you feel relaxed or sleepy. It's often used before medical procedures to help ease anxiety or as a mild sedative.

Will I be paid for taking part?

Sometimes, studies for healthy volunteers offer payment for your time and travel, but this is something you should ask the study team directly.

What if I get side effects?

The study team will monitor you very closely for any side effects and will be available to answer any concerns. Your safety is their top priority.

How long will the study last for me?

The exact duration of your participation will be explained by the study team, as it can vary, but these early studies typically involve a series of visits over a specific period.