Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A phase I, open-label, single dose, mass balance trial to investigate metabolism and pharmacokinetics of BI 1291583(C-14) administered as oral solution in healthy male subjects

This research is a Phase I study, which means it's one of the first times this new medicine, BI 1291583, is being tested in people. The main goal is to understand how the body handles this medicine. Specifically, researchers want to see how much of the medicine is absorbed, how it's broken down, and how it eventually leaves the body, mainly through urine and stools. Healthy men will be given a single dose of the medicine, which has a special, safe label (C-14) to help researchers track it accurately. This helps scientists learn vital information about the medicine's journey through the body before it can be tested in patients who might benefit from it.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

14 Apr 2023

Healthy

What is this study about?

This study is a very early step in developing a new medicine called BI 1291583. Think of it like a detective story: researchers want to track exactly what happens to this medicine once it enters the body. They need to find out how much of the medicine is absorbed, where it goes, how long it stays, and how the body eventually gets rid of it. This information is really important because it helps scientists understand what dose might be effective and safe in the future.

To do this, healthy men will receive a single dose of the medicine. This medicine has been specially marked with a very tiny, safe amount of a substance called C-14. This C-14 acts like a tiny tracker, allowing researchers to follow the medicine's journey through the body using special tests. They will collect samples of urine and stools over time to measure how much of the marked medicine leaves the body. They will also take blood samples to see how much of the medicine is in the bloodstream and how long it stays there.

This type of study, called a 'mass balance trial,' is a standard and necessary part of developing any new medicine. It gives scientists crucial information about a medicine's 'pharmacokinetics' and 'metabolism' – basically, how the body processes it. Understanding this helps ensure that if the medicine moves to later stages of testing, it will be done as safely and effectively as possible.

Key takeaways

This is an early study of a new medicine called BI 1291583.
It aims to understand how the body processes and gets rid of the medicine.
Healthy men will take a single dose of the medicine.
Researchers will track the medicine using special laboratory tests on blood, urine, and stool samples.
Your participation would help advance medical research for potential future treatments.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You'll need to be at least 18 years old, and there is no upper age limit specified, as long as you are generally healthy.

Because this is a very early-stage study to understand how a new medicine works in the body, it's important that participants are healthy. This helps researchers focus solely on how the medicine behaves without other health conditions affecting the results.

Further specific health checks will be carried out by the study team to make sure you're suitable and that taking part would be safe for you.

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 generally consider yourself to be in good health?
Are you willing to stay in a clinic for observation?
Are you comfortable providing blood, urine, and stool samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first have a screening visit to check your general health and make sure you meet all the study requirements. This will likely involve a physical exam, blood tests, and other assessments.

If you are suitable, you will be admitted to a special clinic or unit for a period. During this time, you will receive a single dose of the study medicine, taken as a liquid. After taking the medicine, the research team will closely monitor you. They will collect samples of your urine and stools regularly over a set period to track how the medicine leaves your body. They will also take blood samples at different times to measure the medicine's levels in your bloodstream.

The entire duration of your stay in the clinic and the follow-up period will depend on how long it takes for the medicine to be cleared from your body and for all necessary samples to be collected. There will likely be follow-up visits or calls after you leave the clinic to ensure your well-being.

Potential risks and benefits

Potential benefits of taking part include contributing to medical science and helping to develop new medicines that could help many people in the future. You will also receive thorough health check-ups throughout the study. However, this study might not offer direct personal health benefits, as its main purpose is to gather information about the medicine. As with any medicine, there are potential risks, such as side effects from the study drug, discomfort from blood tests, or other procedures. The research team will explain all potential risks in detail, and your safety will be carefully monitored. Remember, 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.

—
Unverified
Netherlands

Common questions

What is a 'Phase I' study?

It's one of the very first studies in people, usually healthy volunteers, to understand how a new medicine works in the body and if it's safe enough to continue testing.

Why is it important to track the medicine in urine and stools?

This helps scientists see how much of the medicine the body absorbs and how much is eventually removed from the body, which is crucial for understanding its effects.

What does 'C-14' mean on the medicine?

It's a special, safe label that acts like a tiny tracker. It allows researchers to follow the medicine's journey through your body very accurately without causing any harm.

Will I get better if I take part?

This study is not designed to treat any illness. Its main purpose is to gather information about a new medicine in healthy people, so there are no direct health benefits expected for participants.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care or your relationship with the study team.