Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test how different doses of BI 3731579 are tolerated by healthy people

This is a very early study, called a Phase 1 trial, and it's looking for healthy volunteers to help test a new medication known as BI 3731579. The main goal is to find out how well your body tolerates different doses of this new medicine. Researchers will be checking for any side effects and seeing how the medicine affects people in general. Because it's such an early stage, it helps scientists understand the medication better before it's given to people with specific illnesses. Your health and safety will be carefully monitored throughout the study. This trial is important for helping to develop new treatments for the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

19 Nov 2024

Healthy volunteer trial

What is this study about?

Imagine scientists have created a brand new key, but they don't know if it will unlock different doors safely. This study, called a 'Phase 1' trial, is a bit like that. It's one of the very first steps in testing a new medicine, called BI 3731579. The main purpose is not to treat a specific illness, but to understand how this new medicine works in the human body when given to healthy people.

The researchers want to find out how different amounts (or 'doses') of BI 3731579 are handled by the body. They will carefully watch for any side effects and learn how the medicine behaves. This information is really important because it helps them decide what dose might be safe and effective in later studies, which will involve people with particular illnesses.

Taking part in this kind of study is a crucial step in developing new medicines. It helps to make sure that any future treatments are as safe and effective as possible. Your health and wellbeing will be the top priority for the study team during your time in the trial.

Key takeaways

This is a study for healthy volunteers.
It tests a new medicine called BI 3731579.
The main goal is to check for safety and how the body handles different doses.
It's a very early stage of medicine development.
Your health will be closely monitored throughout.

Who may be eligible?

This study is looking for a variety of people, both men and women, of different ages. You need to be at least 18 years old to take part, and there isn't an upper age limit specified. The most important thing is that you are generally healthy.

Being 'healthy' means you don't have any major ongoing medical conditions that could make taking the new medicine risky or affect the study results. The medical team will check this carefully with you before you can join. They'll ask about your medical history and do some health checks.

If you have certain health problems, or are on particular medications, you might not be able to join. The study team will review all your information to make sure it's safe for you to take part and that you meet all the requirements.

Quick self-check

Am I at least 18 years old?
Do I consider myself to be generally healthy?
Am I willing to attend regular clinic visits?
Am I comfortable taking a new, untested medicine?
Do I understand I will be carefully monitored?

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 first have some health checks to make sure you're suitable for the study. If you're eligible, you'll be given the new medicine, BI 3731579. This will be at different doses, which the study team will explain to you.

Throughout the study, you'll have regular visits to the clinic. During these visits, the doctors and nurses will carry out various assessments, such as blood tests, heart checks, and will ask you questions about how you're feeling. This is to closely monitor your health and how your body is reacting to the medicine.

The study will involve several visits over a specific period, but the full duration isn't mentioned here. There will also be follow-up appointments after you stop taking the medicine to ensure you are well. All procedures will be explained clearly to you before you agree to anything.

Potential risks and benefits

Because this is one of the first times this medicine is being given to people, there might be risks that are not yet fully known. Potential risks could include side effects, which might be mild (like a headache) or, very rarely, more serious ones. You will be closely monitored by medical staff to quickly identify and manage any issues. While there may be no direct health benefit to you as a healthy volunteer, your participation is very important to help develop new medicines that could help many people in the future. Remember, you have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Belgium

Common questions

What is BI 3731579?

It's a new medicine created by scientists that they are testing for the very first time in people. Its exact purpose isn't explained in this early phase.

Why do you need healthy volunteers?

Testing new medicines in healthy people first helps researchers understand how the medicine works and if it's safe before they give it to people who are unwell.

Will this medicine treat a specific illness?

No, this early study is not about treating an illness. It's about seeing how the medicine acts in the body of healthy people and checking for side effects.

How long will I need to be in the study?

The information provided doesn't state the exact length of the study, but it will involve several clinic visits for tests and monitoring over a period of time.

Do I have to take part if I'm interested?

No, you never have to. You'll receive lots of information, and you can decide if you want to join. You can also leave the study at any time.