Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy men and women to test whether BI 1569912 influences the amount of repaglinide, midazolam and bupropion in the blood

This study will involve healthy men and women aged 18 and over. The main goal is to find out if a new medicine, called BI 1569912, changes how much of three other commonly used medicines (repaglinide, midazolam, and bupropion) stays in your blood. This is important because medicines can sometimes affect each other, and understanding these interactions helps doctors prescribe them safely. This is an early-stage study, often called a Phase 1 study, which means it helps us learn more about how the new medicine works in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

30 Apr 2024

Healthy volunteer trial

What is this study about?

Imagine you take two different medicines at the same time. Sometimes, one medicine can change how the other one works in your body. It might make the second medicine stronger, weaker, or stay in your system for a longer or shorter time. This study is designed to look at exactly that kind of interaction for a new medicine called BI 1569912.

Researchers want to see if BI 1569912 affects how three other common medicines behave in your body. These medicines are repaglinide (used for diabetes), midazolam (a calming medicine), and bupropion (used for depression or to help stop smoking). By understanding these interactions, doctors can be more confident when prescribing BI 1569912 with other treatments, making sure everyone gets the safest and most effective care.

This is a very early stage of testing for BI 1569912 in people. Studies like this are crucial because they help us get important information about new medicines before they can be used more widely. It’s all about making sure new treatments are as safe and effective as possible.

Key takeaways

This study is for healthy adults aged 18 and over.
It checks how a new medicine, BI 1569912, interacts with other common medicines.
Participation involves taking study medicines and having regular blood tests.
Your involvement helps improve medicine safety for future patients.
It's an early-stage study to gather important information about the new drug.

Who may be eligible?

To join this study, you need to be a healthy man or woman who is at least 18 years old. There is no upper age limit, meaning older adults are welcome to participate if they meet the other health criteria.

Being healthy for this study means you generally don't have any major ongoing medical conditions that could interfere with the study medicines or results. The research team will do checks to make sure you are suitable.

Quick self-check

Are you 18 years old or older?
Are you generally healthy, without significant long-term illnesses?
Are you comfortable taking new medicines as directed?
Are you able to commit to several clinic visits and potentially overnight stays?

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 doses of the new medicine (BI 1569912) and the other study medicines (repaglinide, midazolam, and bupropion) at specific times. You will need to come to the study clinic for several visits, which may include overnight stays. During these visits, the study team will take blood samples regularly to measure how much of the medicines are in your system. They will also check your general health, like your blood pressure and heart rate. The total time you would be involved in the study, from your first visit to your final follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study, but your participation helps doctors learn more about how medicines interact, potentially helping many others in the future. As with any medicine, there's a chance you could experience side effects from the study drugs. The research team will carefully monitor you for these and explain them fully beforehand. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason.

Locations (1)

—
Belgium

Common questions

What is a 'healthy volunteer trial'?

It means the study is looking for people who are generally well, without major health problems, to help test a new medicine safely.

What is BI 1569912?

It's a new medicine being developed. This study aims to understand how it acts in the body, especially when taken with other common medicines.

Will I receive any of the medicines for my own health?

No, this study is not for treatment. You will receive the medicines to help researchers understand how they interact, as part of the study process.

How long will the study participation last?

The full duration, including clinic visits and any follow-up, will be clearly explained by the study team. It will vary depending on the study design.

Will I be paid to take part?

Often, healthy volunteer studies offer some payment for your time and inconvenience. This will be discussed with you before you agree to participate.