Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy people to test how 3 different formulations of BI 764198 are taken up in the body and how this is influenced by food

This study is for healthy people and is testing a new medicine called BI 764198. We are looking at three different ways the medicine might be made (formulations) to see how your body takes it in. We also want to find out if eating food before or after taking the medicine affects how it works. This is an early-stage study, meaning it's one of the first times this medicine is being given to people. It's done very carefully to make sure it's safe and to learn important information about how the medicine behaves in the body before it can be given to patients with specific health conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

21 Mar 2025

healthy volunteer trial

What is this study about?

This research study is about a new potential medicine called BI 764198. We don't know yet what health condition this medicine might treat, but this early study is a very important first step. We're asking healthy volunteers to help us understand how their bodies handle this new medicine.

The main goal is to find out how well your body absorbs BI 764198 when it's given in three slightly different ways (these are called 'formulations'). Think of it like comparing three slightly different ways to make a tablet – we want to see which one the body takes up best. We're also curious if eating food around the time you take the medicine changes how much of it gets into your system.

This type of study is called a 'Phase I' or 'Human Pharmacology' study. It means it's one of the very first times this medicine is being given to people, not to treat a disease, but purely to understand its basic effects and safety in the human body. The information we gather will help researchers decide the best way to give this medicine in future studies, potentially for people who could benefit from it.

Key takeaways

Tests a new medicine (BI 764198) in healthy volunteers.
Aims to understand how the body absorbs different forms of the medicine.
Investigates if food affects medicine absorption.
It's an early-stage (Phase I) study, focused on safety and basic understanding.
Open to healthy adults aged 18 and over, both men and women.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. This means you generally don't have any major ongoing health problems, and you're not currently taking medications that could interfere with the study.

More detailed checks will happen if you express an interest. A study doctor and nurse will carefully review your health and medical history to make sure that taking part is safe for you. They will explain specific health requirements and any medications you might need to avoid during the study.

Even though the study says 'any' for the upper age range, you will still need to be fit and healthy for your age, as determined by the study team. Both men and women are welcome to take part.

Quick self-check

Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you able to follow study instructions carefully?
Are you willing to potentially stay overnight at a clinic?
Are you happy to have blood samples taken regularly?

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 likely need to spend some time at a research clinic. This usually involves staying overnight for several days at a time, or coming in for multiple visits over a period of weeks or months. During these stays or visits, you'll be given one of the different forms of the BI 764198 medicine.

The study team will take blood samples regularly to see how the medicine levels change in your body. You might also have other checks like blood pressure, heartbeat (ECG), and general health assessments. Sometimes, participants are asked to fast (not eat) for a certain period before taking the medicine, and then eat a meal afterwards, so the researchers can see the effect of food. There will also be follow-up calls or visits after you've finished taking the medicine to ensure you are well. The total duration of your participation could range from a few weeks to a couple of months, depending on the study design.

Potential risks and benefits

Because this is an early-stage study, we don't expect direct health benefits for you from taking part. The benefit is to science, by helping us learn more about this potential new medicine. There are always some potential risks with any medicine, even in healthy people. These might include side effects like headaches, tummy upsets, or reactions at the site where blood is taken. The study team will explain all known or potential risks in detail, and your safety will be carefully monitored throughout. 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

Why are you looking for healthy people?

We recruit healthy people in early studies like this to understand how a new medicine works in the body without other health conditions making it complicated.

What does 'formulation' mean?

It refers to the way the medicine is made – like different types of tablets or liquids – to see which one works best.

Will I get paid for taking part?

Many healthy volunteer studies offer payment for your time, travel, and inconvenience. This will be fully explained before you agree to take part.

How long will I be in the study?

The length varies, but it usually involves several clinic visits or stays over a few weeks or months. The exact duration will be explained to you.

What happens if I feel unwell during the study?

The study team will be available 24/7 to monitor your health and address any concerns or side effects you might experience.