Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study to test how well different doses of BI 3810477 are tolerated by healthy men

This research study is inviting healthy men, aged 18 and older, to take part. It's an early-stage study, meaning it's the very first time this new medicine, called BI 3810477, is being given to people. The main goal is to carefully check how the body reacts to different amounts (doses) of this medicine. Researchers want to find out if it's safe and how well people tolerate it, meaning if it causes any unwanted effects. This type of study is important for understanding new medicines before they can be tested in larger groups of people who might have specific health conditions. By taking part, you would be helping medical science learn more about this potential new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

14 Oct 2024

Healthy volunteer trial

What is this study about?

This study is an early step in developing a new medicine, which has been given the code name BI 3810477. Before any new medicine can help people with illnesses, it must first be carefully tested for safety in healthy volunteers. That's what this study is all about. It's the very first time this particular medicine is being given to humans, so the researchers will be extra careful and start with very small amounts.

The main purpose of this research is to see how different doses of BI 3810477 are handled by the body and if they cause any side effects in healthy men. This is called 'human pharmacology' and it helps scientists understand how the medicine behaves once it's inside a person. They will be looking closely at how much medicine stays in the body, how it's broken down, and how quickly it leaves.

Even though this study doesn't look at treating a specific illness, it's a very important step. The information gathered from healthy volunteers helps scientists decide if the medicine is safe enough to be tested in people who might have a health condition it's designed to treat. Your participation helps pave the way for potential future treatments.

Key takeaways

It's a very early-stage study for a new medicine, BI 3810477.
Only healthy men aged 18 and over can take part.
The main goal is to check safety and how the body reacts to the medicine.
You would be closely monitored by doctors and nurses.
There are no direct personal health benefits expected.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

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

To be considered 'healthy' for this study means you generally don't have any major ongoing medical conditions, you're not taking certain medications, and your organs are working well. The research team will conduct a thorough health check to make sure you're suitable.

They're interested in testing this new medicine only in men for this initial phase. If you're a woman, or if you have certain health issues, or are taking regular medications that could interfere with the study, then this particular study would not be suitable for you.

Quick self-check

Are you a man?
Are you 18 years old or older?
Are you generally in good health?
Do you not have any major ongoing medical conditions?
Are you able to follow study instructions and attend all appointments?

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 would first have a screening visit. This is where medical checks like blood tests, a physical exam, and a review of your health history would happen to confirm you're healthy and suitable for the study. If you get the green light, you would then receive doses of the new medicine, BI 3810477. This would involve staying at the study clinic for a period, where nurses and doctors can carefully monitor you. You'd have regular tests, such as blood pressure checks, heart readings (ECG), and blood samples, to see how your body is reacting to the medicine. You would likely receive different doses over time, or be part of a group receiving a specific dose. After receiving the medicine, there would be follow-up visits to ensure your well-being. The total duration of your participation, including all visits and follow-ups, would be explained fully by the study team.

Potential risks and benefits

Because this is the first time this medicine is being given to humans, there might be benefits to medical science more than direct personal benefits to you. You wouldn't be receiving treatment for an illness. The potential risks involve experiencing side effects from the new medicine, which could be mild, like a headache, or more serious, though every precaution is taken to minimise these. There's also the chance of discomfort from study procedures, such as blood draws. You will be closely monitored by medical staff throughout. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Belgium

Common questions

What is BI 3810477?

BI 3810477 is a new experimental medicine that has not been given to humans before. This study is testing its safety and how the body handles it.

Will I feel better from taking part in this study?

This study is not designed to treat an illness, so you won't necessarily feel better. It's about finding out how the new medicine works in healthy people.

How long will I need to be involved in the study?

The exact length of your participation, including hospital stays and follow-up visits, will be explained by the study team before you consent. It varies depending on the specific group you might join.

Will I get paid for taking part?

Many early-stage healthy volunteer studies offer payment for your time and inconvenience. The study team will be able to tell you if this is the case for this study.

What happens if I change my mind?

You are free to leave the study at any point, for any reason. Your decision will not affect any medical care you receive in the future.