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

A study in healthy men to test how well different doses of BI 3731579 are tolerated

We're inviting healthy men to take part in an important early study. The main goal is to test a new medicine, called BI 3731579, to understand how it affects the body when given for the first time. Specifically, we want to see how well different amounts (doses) of this medicine are tolerated and if they cause any side effects. This is a "first-in-human" study, which means it's one of the earliest stages of testing a new medicine. It's done to gather crucial safety information before it can be explored in people with specific health conditions. Your participation would help medical researchers 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

16 May 2024

Healthy volunteer trial

What is this study about?

This research study is about a new medicine called BI 3731579. We're in the very first stages of testing it, which is often called a 'Phase I' study or 'human pharmacology' phase. This means it's the first time this specific medicine is being given to people. The main purpose is to learn how the human body reacts to it.

Researchers want to see how different amounts, or 'doses', of BI 3731579 are handled by the body. They will be looking closely for any side effects and how well people tolerate the medicine. This early safety information is really important because it helps scientists understand if a new medicine is safe enough to be tested further in larger groups of people, including those who might have a particular illness.

By taking part, you would be helping medical science explore a potential new treatment. Studies like this are a crucial first step in bringing new medicines to people who need them. Your involvement, as a healthy volunteer, helps gather essential information that can guide future research and development.

Key takeaways

It's a study for healthy men, aged 18 or over.
The main goal is to test the safety of a new medicine, BI 3731579.
Researchers will check how different doses are tolerated and for side effects.
Your participation helps advance medical research, though there's no direct health benefit for you.
You will be closely monitored by medical staff during the study.
You have the right to leave the study at any time.

Who may be eligible?

This study is specifically looking for healthy volunteers. This means you should generally be in good health and not have any ongoing medical conditions that might affect how your body responds to the medicine being tested.

To be eligible, you must be a man. We are looking for men who are 18 years old or older. There is no upper age limit, as long as you meet the other health criteria.

Because this is a specific type of study, other health checks will be done by the study team to make sure it's safe for you to take part. For example, they will check your medical history, do a physical exam, and might take blood or urine samples to confirm you are in good health.

Quick self-check

Are you a man?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Do you not have any major ongoing medical conditions?

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 be given the study medicine, BI 3731579, at a specific dose. You would likely need to stay at the study clinic for a set period, possibly overnight or for a few days, especially when you first receive the medicine. During this time, the study team will closely monitor your health.

This will involve various assessments, such as regular blood tests, urine tests, checking your blood pressure and heart rate, and asking you about how you are feeling. These checks are to understand how your body is reacting to the medicine and to look for any side effects. You might also have follow-up visits after you leave the clinic to make sure you remain well. The total duration of your participation, including all visits and follow-ups, would be explained to you in detail before you agree to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For healthy volunteers, the main benefit is contributing to medical research and helping to develop new medicines that could help others in the future. There is no direct personal health benefit expected for you from taking this medicine, as it's an early safety test. Potential risks might include experiencing side effects from the experimental medicine, which could be mild (like a headache or feeling tired) or, in rare cases, more serious. You will be closely monitored to identify any issues quickly. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is a 'healthy volunteer' study?

It's a study where people who are generally well, without major health problems, try a new medicine for the first time. The aim is to check its safety and how the body handles it.

Will this medicine help my health?

No, not directly. This early study is for safety testing, not to treat an illness. However, your participation helps find new treatments for others in the future.

What does 'dose' mean?

The 'dose' is the specific amount of the medicine you would be given. Researchers test different doses to see how the body reacts to varying amounts.

How long will I need to be involved?

The total time you'd be involved, including clinic stays and follow-up visits, will be fully explained before you agree to join. It varies depending on the study's specific plan.

Can I stop taking part if I change my mind?

Yes, absolutely. You can withdraw from the study at any point, for any reason, and it won't affect your normal medical care.