Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy men to test whether BI 1815368 influences the amount of metformin in the body

This research study is for healthy men and is designed to find out how a new medicine, called BI 1815368, might change the levels of another drug, metformin, in the body. Metformin is a widely used medication, often prescribed for people with diabetes. This kind of study is a very early step in checking new medicines. It's called a 'Phase I' trial, which means it helps scientists understand basic information about how a drug works and how safe it is in healthy people. The main goal is to see if BI 1815368 affects how much metformin is absorbed, used, or removed from the body. This information is important for potentially developing new treatments in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

09 Oct 2024

Healthy volunteer trial

What is this study about?

This study is looking into a new medicine called BI 1815368. The main purpose is to see how this new medicine interacts with another common drug called metformin. Metformin is a well-known treatment, mostly used for people with type 2 diabetes. By understanding how BI 1815368 affects metformin levels in healthy people, researchers can gather important safety information and learn more about how the new drug works.

This is an early-stage study, often called a 'Phase I' trial. This means it's one of the first times this new medicine is being tested in people. Before any new medicine can be given to a lot of people, scientists need to understand its basic effects and make sure it's safe. Healthy volunteers are crucial for these early stages because their bodies are generally predictable, making it easier to spot any changes caused by the new medicine.

The findings from this study will help researchers understand if BI 1815368 changes how metformin is handled by the body. This could be important for people who might need to take both medicines in the future, as it helps doctors understand how they might work together. It's a key step in the long process of developing new and safer medicines.

Key takeaways

This study is for healthy men, aged 18 and over.
It aims to understand how a new drug, BI 1815368, interacts with metformin.
This is an early-stage (Phase I) study to gather safety and drug interaction information.
Participation will involve clinic visits, taking study drugs, and medical checks.
Your involvement helps advance medical science, but there's no direct personal health benefit.
You can withdraw from the study at any time.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You need to be at least 18 years old to take part, and there's no upper age limit, as long as you meet all the other health requirements.

Being a 'healthy volunteer' means that you generally don't have any major ongoing health conditions or take regular medications that could affect the study results. The research team will do medical checks to make sure you are healthy enough to participate.

Because this study is looking at how a new medicine affects a specific pathway in men, women are not able to take part in this particular study.

Quick self-check

Are you male?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Do you not have any major ongoing medical conditions?
Are you not currently taking any regular medications (this will be checked by the study team)?

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 in this study, you will likely have several visits to a clinic. During these visits, you will undergo various medical checks, such as blood tests, check-ups, and possibly heart scans. You will be given the study medication, BI 1815368, and also metformin, and researchers will carefully monitor how your body reacts. This will involve regular blood samples to measure drug levels.

There might be periods where you stay overnight at the clinic for close observation, especially after taking the medicines. You'll be asked to follow specific instructions on diet and activities during your participation. The total time you spend involved in the study, from your first screening visit to your final follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study carries some potential risks, as the effects of new medicines aren't fully known. You might experience side effects from the study drug, BI 1815368, or from metformin. The research team will carefully monitor you for any problems. You might also have discomfort from blood tests or other procedures. There is no direct personal benefit from taking part in this study, as it's designed to gather information for future patients. However, your participation greatly contributes to medical knowledge and the development of new treatments for others. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is metformin?

Metformin is a common medicine mainly used to treat type 2 diabetes, helping to lower blood sugar levels.

Why are only men included in this study?

Often, early studies focus on one sex to simplify the initial understanding of how a new drug works in the body and to reduce potential variations.

What does 'healthy volunteer' mean?

It means you are generally well, without any major ongoing health issues or regular medications that could interfere with the study results.

Will I receive money for taking part?

Most studies for healthy volunteers offer some payment for your time and travel, but this detail should be confirmed with the study team.

Is this medicine (BI 1815368) already available for patients?

No, this is a very early-stage study, so BI 1815368 is not yet available as a treatment for any condition.