Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy people to test how well repeated doses of BI 3032950 are tolerated

This research study is inviting healthy men, aged 18 and older, to take part. Researchers want to understand how a new medicine, called BI 3032950, affects the body when taken repeatedly. This is a very early stage of testing, often called a 'Phase I' study. It means it's one of the first times this medicine is being given to people. The main focus is on safety: to see if the medicine is well-tolerated and if any side effects happen when doses are given over a period of time. This kind of study helps scientists learn crucial information about a new medicine before it can be tested in people with the condition it's designed to treat.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH

Enrolment target

Start

01 Aug 2023

Healthy

What is this study about?

Imagine a new medicine is being developed, but before it can help patients, scientists need to understand how it works in the human body. This particular study is for a new medicine simply called BI 3032950. It's a very early-stage trial, which means it's one of the first times this medicine is being given to people.

The main aim of this study is to check how safe the medicine is and if people can take repeated doses of it without too many problems. Researchers want to see if the body tolerates the medicine well over a few doses and if there are any side effects that pop up when it's taken more than once. This is a vital step because it helps them understand how the medicine behaves in healthy people before it can be tested in people who actually have a health condition.

Taking part in this kind of study won't directly treat an illness because it's for healthy volunteers. Instead, your participation helps doctors and scientists gather really important information. This information is a crucial building block to see if BI 3032950 has the potential to become a useful medicine in the future. Your contribution would help advance medical knowledge.

Key takeaways

It's a very early-stage study (Phase I) for a new medicine called BI 3032950.
The study is solely for healthy men, aged 18 and older.
The main goal is to check the safety and tolerability of repeated doses of the medicine.
Your participation helps advance medical research, but won't directly treat an illness.
You will undergo health checks and regular monitoring during the study.
You can always withdraw from the study at any point.

Who may be eligible?

To join this study, you need to be a healthy man. This means you shouldn't have any major ongoing health problems or illnesses that could affect how the medicine works or lead to complications. You'll have a health check to make sure you're suitable.

You also need to be at least 18 years old. There isn't an upper age limit mentioned, but all participants will be thoroughly checked by the study doctors to ensure they are healthy enough to take part safely.

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?
Do you consider yourself generally healthy with no major ongoing medical conditions?
Are you able to attend clinic visits as required by the study schedule?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a health check-up to make sure you're suitable. Once confirmed, you would receive doses of the study medicine, BI 3032950, over a period of time. You'll likely need to visit the study clinic multiple times, and some visits might involve staying overnight or for several hours. During these visits, the study team will carry out various tests and assessments, such as blood tests, urine samples, and checking your vital signs like blood pressure and heart rate. This helps them monitor how the medicine is affecting you and if you're experiencing any side effects. After receiving the medication, there will be follow-up visits to ensure your health is stable. The total duration of your involvement, including all visits and follow-ups, would be explained to you before you agree to participate.

Potential risks and benefits

The main benefit of taking part in this early-stage study is contributing to medical science and helping to develop new treatments for the future. You will also receive thorough health checks throughout the study. However, like all medicines, BI 3032950 might have potential side effects, which could range from mild to more serious. The study team will closely monitor you for any unwanted effects. You will be given a complete explanation of all known or potential risks before you decide to join, and 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 a 'healthy' person in this study?

It means you don't have any significant ongoing health problems or illnesses that could interfere with the study medicine or your safety while participating. You'll have a medical check to confirm this.

What is BI 3032950?

It's the name of a new medicine being tested. Its exact purpose isn't explained yet, as this study is mainly focused on its safety in healthy individuals.

Will I get paid to take part?

Payment for participation to compensate for your time and inconvenience is common in early-stage trials. This would be explained in detail if you inquire further about the study.

Could I get a placebo (dummy medicine) instead of the real medicine?

Some studies use placebos, but the information provided doesn't specify for this trial. If a placebo may be used, the research team will explain this to you clearly.

How long will the study last for me?

The information doesn't specify the exact duration, but all details about the number of visits, overnight stays, and follow-up period will be given to you by the study team.