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

A study in healthy men to test how different doses of BI 3031185 are tolerated and how food influences the amount of BI 3031185 in the blood

This study is for healthy men, aged 18 and older, to help us understand a new medicine called BI 3031185. This is one of the very first times this medicine is being given to people. We want to find out how well people tolerate different amounts (doses) of BI 3031185. We'll also be checking how much of the medicine gets into the blood and whether eating food before or after taking it makes a difference. The information we gather will help us decide how to test this medicine further in the future. Your participation would be really valuable in helping advance medical research.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

16 Feb 2024

Healthy volunteer trial

What is this study about?

This study is designed to learn more about a new medicine called BI 3031185. It's a very early study, meaning it's one of the first times this medicine will be given to people. We call this a 'Phase I' study. The main goals are to make sure the medicine is safe for people to take and to understand how it behaves in the body.

Specifically, researchers want to see how different amounts, or 'doses,' of BI 3031185 are handled by the body. They'll be watching closely for any side effects and how well the treatment is tolerated. Another important part of the study is to see how food might affect the medicine. Sometimes, taking a medicine with food can change how much of it gets absorbed into the bloodstream. Understanding this helps doctors know the best way for people to take the medicine in the future.

Even though you are healthy, your participation in this study is extremely important. The information gathered from healthy volunteers allows researchers to understand the basic safety and behaviour of a new medicine before it is given to patients who might be unwell. This careful step-by-step approach is crucial for developing new and effective treatments.

Key takeaways

This is a very early study of a new medicine called BI 3031185.
It's open to healthy men aged 18 and over.
The main goals are to check safety, how the body handles the medicine, and if food affects it.
You won't get any personal health benefits, but you'll help advance medical knowledge.
You will be closely monitored by a medical team.
You can stop participating at any time.

Who may be eligible?

To take part in this study, you need to be a healthy man. This means you generally feel well and don't have any significant ongoing health problems or illnesses that would make it unsafe for you to participate.

You also need to be at least 18 years old. There's no upper age limit mentioned, but typically, healthy volunteers need to be able to safely complete all study procedures.

The study is only open to men. If you are female, you would not be able to join this particular study.

Quick self-check

Are you a man?
Are you 18 years old or older?
Do you generally feel healthy and well?
Are you able to commit to the study visits and requirements?

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 will be given doses of the new medicine, BI 3031185. You will likely need to stay at a clinic for a period of time so that doctors and nurses can closely monitor you. They will perform various assessments, which might include blood tests, urine tests, checking your heart rate and blood pressure, and asking you how you are feeling. These assessments help them understand how your body reacts to the medicine and how much of it is in your blood. You may also be asked to take the medicine with or without food to see if it makes a difference. After your time at the clinic, there might be some follow-up visits to make sure you are still doing well. The total duration of your involvement could range from a few days to a few weeks, depending on the specific study plan.

Potential risks and benefits

Taking part in this study means you could be one of the first people to help researchers learn about a new medicine. There are no direct personal health benefits for you, as the study is about understanding the medicine's behaviour in healthy people. However, you will be contributing valuable information that could lead to new treatments for others in the future. As with any new medicine, there's always a chance of experiencing side effects, some of which might be unknown. The study team will closely monitor you for any changes in your health. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What does 'healthy volunteer' mean?

It means you generally feel well, don't have any major ongoing health problems, and aren't taking regular medications that could interfere with the study.

Why is this study only for men?

Sometimes, early studies focus on one sex to better understand how a medicine works without the added complexity of potential differences between men and women. Future studies might include women.

Will I be paid to take part?

Many early-stage studies offer payment for your time and inconvenience. This would be discussed with you before you agree to join.

What happens if I feel unwell during the study?

The study team will be closely monitoring you. If you feel unwell, you should tell them immediately, and they will provide any necessary care.

How long will I be involved in the study?

The total time you spend in the study, including clinic stays and follow-up, will be clearly explained to you before you agree to take part. It varies depending on the specific study design.