Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy people to test how BI 1015550 is taken up in the body when given with or without food

This study is for healthy volunteers and aims to understand how a new medicine, BI 1015550, behaves once it's in the body. Specifically, we want to find out how well the body takes up this medicine and whether eating food at the same time makes a difference. This kind of research, called a 'Phase 1' study, is an early step in developing new medicines. It helps us learn important things about how the medicine works in people before it is given to patients with a specific illness. Your participation helps advance medical science.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

17 Apr 2024

Healthy volunteer trial

What is this study about?

Imagine you're trying a new recipe, and you want to know if adding a certain ingredient changes the taste. In a similar way, this study is like testing a new medicine, BI 1015550, to see how it's absorbed by your body.

When you take a medicine, your body has to take it in from your stomach and put it into your bloodstream so it can travel to where it needs to work. This study is designed to see if food makes a difference to this process. Some medicines are absorbed better with food, others without, and some are not affected at all. Understanding this is really important because it helps doctors and pharmacists know how to advise people to take the medicine for the best effect.

This is a very early stage study, often called a 'Phase 1' or 'Human Pharmacology' study. It means we're not looking at treating a specific illness, but rather gathering basic information about the medicine's safety and how it moves through healthy bodies. The information we gain from studies like this is crucial for the development of new medicines that could help many people in the future.

Key takeaways

This study is for healthy adults, aged 18 and over.
It aims to understand how a new medicine, BI 1015550, is absorbed by the body.
Researchers want to know if food affects how the medicine is taken up.
This is an early-stage study, helping develop future medicines.
Participation involves taking the study medicine and regular health checks.

Who may be eligible?

This study is looking for healthy adults. You must be at least 18 years old to take part, and there's no upper age limit, as long as you are generally healthy.

Both men and women are welcome to participate in this study. The main requirement is that you are in good health. This means you shouldn't have any serious ongoing medical conditions or be taking medications that might interfere with the study medicine.

Quick self-check

Are you 18 years old or older?
Do you consider yourself generally healthy?
Do you not have any major ongoing health conditions?
Are you not currently taking medicines that might interfere with the study?

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 will be given the study medicine, BI 1015550. In some instances, you might take the medicine with food, and in others, you might take it without. Doctors, nurses, and other study staff will carefully monitor you throughout your time in the study. This will likely involve regular checks of your health, such as blood pressure and heart rate measurements, and blood samples to see how the medicine is moving through your body. The exact number of visits, how long each visit lasts, and the total duration of your participation will be explained in detail by the study team, but typically, these early phase studies involve several visits over a period.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of participating is contributing to medical research that could lead to new treatments for future patients. However, you will not receive any direct health benefit from being in this study since you are healthy. Potential risks might include side effects from the study medicine, which will be carefully explained to you. These could be mild, like a headache, or more serious, though rare. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is a 'healthy volunteer' study?

It's a study where people who are generally well, without any major health problems, take part to help us understand how a new medicine works in the body.

What is BI 1015550?

It's a new medicine being developed. In this study, we are just learning how it acts in the body, not using it to treat a specific illness.

Will I get paid to take part?

Payment for participation in clinical trials varies. This will be explained in full detail by the study team if it applies.

How long will the study last for me?

The full details of the schedule, including the total time you would be involved, will be given to you by the study team before you decide to join.

What does a 'Phase 1' study mean?

It's the very first stage of testing a new medicine in people. The main goals are to check its safety and how the body handles it.