Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy people to test how 2 different formulations of BI 690517 are taken up in the body and how probenecid influences the amount of BI 690517 in the blood

This study is for healthy volunteers and aims to understand how our bodies handle a new medicine called BI 690517. Specifically, researchers are testing two slightly different versions (called formulations) of this medicine to see which one is absorbed best. They also want to find out if another widely used medicine, probenecid, affects how much BI 690517 stays in your blood. This type of study, called a Phase I trial, is an early step in developing new medicines. It helps scientists learn important information about how a medicine works and is processed by the body, which is crucial before it can be tested in people who are unwell.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

11 Sep 2024

Healthy volunteer trial

What is this study about?

This research study is about understanding a new medicine called BI 690517. It's a very early stage of drug development, known as a Phase I study, where the main goal is to learn how a medicine behaves in healthy people. Think of it like trying out a new recipe – you want to know how the ingredients mix and what the final product will be like before you serve it to guests.

In this study, researchers are focusing on two key things. Firstly, they want to compare two slightly different versions (or "formulations") of BI 690517. They want to see if changing the way the medicine is made affects how much of it gets into your bloodstream and how quickly. This is important because it helps them find the best way to give the medicine in the future. Secondly, they're looking at how another common medicine called probenecid might interact with BI 690517. Probenecid is sometimes used to help other medicines stay in the body longer, and the researchers want to see if it has a similar effect on BI 690517.

The findings from this study will help scientists understand how BI 690517 is processed by the body (this is called "pharmacokinetics"). This information is vital for deciding the right dose and how often the medicine should be given in future studies involving patients who might benefit from it. By taking part, healthy volunteers contribute significantly to the development of new treatments.

Key takeaways

It's a study for healthy people.
Researchers are testing two ways of giving a new medicine, BI 690517.
They also want to see if probenecid affects the new medicine.
The findings will help develop the medicine for future use.
Participation involves clinic visits and health checks.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you must generally be in good health and not have any serious ongoing medical conditions. The study team will conduct health checks to confirm this.

There isn't an upper age limit mentioned, so adults of any age (18 and over) could potentially participate, as long as they meet all the other health requirements. Both men and women are welcome to join this research.

Quick self-check

Are you 18 years old or older?
Are you generally in good health?
Are you willing to attend regular clinic visits?
Are you open to taking study medicines as instructed?

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 be giving your time for a series of visits to the study clinic. These visits will involve various assessments, such as blood tests to measure the levels of BI 690517 in your body and general health checks. You will receive different versions of the study medicine, BI 690517, at different times, and in some parts of the study, you'll also take probenecid. The total duration of your participation, including all visits and follow-up, will be clearly explained by the study team. You might need to stay overnight at a clinic for certain parts of the study.

Potential risks and benefits

Potential benefits of participating include contributing valuable information to medical science, which could help develop future treatments, and receiving health checks throughout the study. As with all medicines, there are potential risks, including side effects from BI 690517 or probenecid, which the study team will explain in detail. 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 BI 690517?

BI 690517 is a new medicine being developed. This study aims to understand how it works in the body.

What does 'healthy volunteer' mean?

It means you are generally well and don't have any major ongoing health problems.

What is probenecid?

Probenecid is an existing medicine that is sometimes used to help other medicines stay in the body longer.

Will I get sick from these medicines?

The study team will carefully monitor your health. All possible side effects will be explained to you before you agree to take part.

How long will the study last for me?

The exact duration for each participant will be explained by the study team, as it can vary depending on the study plan.