Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test how well different doses of BI 1815368 are tolerated by healthy men

This research study is for healthy adult men aged 18 and older. The main aim is to carefully examine a new medicine called BI 1815368. Researchers want to understand how different amounts, or doses, of this medicine are tolerated by the body. This means they will look at whether people taking it feel well and if there are any side effects. This is a very early stage of testing for new medicines, sometimes called a "Phase I" study. It's an important step to make sure a medicine is safe before it can be tested in people who are unwell. If you're a healthy man and meet the requirements, you could help scientists learn more about this new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

30 May 2023

Healthy

What is this study about?

This study is an early-stage research project designed to learn more about a new medicine called BI 1815368. In this first step, researchers don't give the medicine to people who are ill. Instead, they give it to healthy adult volunteers to understand how it works in the body and if it's safe.

The main aim of this study is to find out how different amounts, or "doses," of BI 1815368 are handled by the body. They want to see how well people tolerate it, meaning if it causes any discomfort or unwanted effects. This information is crucial because it helps scientists decide the right amount of medicine to give in future studies, ensuring it's as safe as possible for patients who might eventually need it.

Taking part in this kind of study is a vital step in developing new medicines. It helps researchers gather important safety information before the medicine can be tested in people with specific conditions. Your participation could contribute to medical progress, even though this particular study is focused on healthy individuals.

Key takeaways

This is an early study of a new medicine, BI 1815368.
It's for healthy men aged 18 and over.
The main goal is to check how safe different doses are.
Participation involves clinic visits and careful health checks.
It's a way to contribute to future medical treatments.

Who may be eligible?

This study is specifically looking for volunteers who are healthy men. You must be at least 18 years old to take part. There is no upper age limit mentioned, so men over 18 of any age are welcome to consider participating.

The most important thing is that you are in good general health. This means you shouldn't have any major ongoing health problems or conditions that might affect how your body reacts to the new medicine.

Because this is an early study, strict health checks will be carried out to make sure you are suitable and that participating would be safe for you. The study team will explain everything and answer any questions you have about whether you can join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man?
Are you 18 years old or older?
Are you generally healthy with no major ongoing medical conditions?
Are you able to attend appointments at the study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it would involve several visits to a clinic. You would receive the study medicine, BI 1815368, in different doses as part of the research plan. During your visits, the research team would closely monitor your health. This usually includes checks like blood tests, urine tests, measuring your heart rate and blood pressure, and asking you how you are feeling.

These assessments help the researchers understand how your body is reacting to the medicine and if there are any side effects. You might need to stay at the clinic for a short period during these visits. The total length of your participation, including any follow-up appointments after you've taken the medicine, will be explained fully by the study team before you agree to take part.

Potential risks and benefits

Potential benefits of taking part in this study include contributing to medical science and helping to develop new medicines that could help many people in the future. You will also receive careful medical monitoring throughout the study. Every medical study carries some potential risks; with a new medicine, these could include unexpected side effects, which the research team will explain fully. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is the medicine BI 1815368?

It's a new medicine that is being tested for the very first time in healthy people to see how it works and if it's safe.

Why are healthy men needed for this study?

Early studies like this use healthy volunteers to understand how a new medicine behaves in the body without other health conditions complicating the results.

Will I get paid for taking part?

Clinical trials often offer reimbursement for your time and travel, but this would be confirmed by the study site if you inquire.

What does 'tolerated' mean in this study?

It means the researchers want to see how well your body handles the medicine, whether it causes any unwanted effects, and if it's generally safe at different doses.

How long will the study last if I join?

The total duration of your involvement, including all visits and follow-ups, will be clearly explained by the study team when you contact them.