Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy men to test whether carbamazepine influences the amount of BI 1810631 in the blood

This research is a 'Phase 1' study, which means it's one of the first times this new drug, BI 1810631, is being given to people. The main goal is to find out if taking the common epilepsy and nerve pain medicine, carbamazepine, at the same time changes the levels of BI 1810631 in a man's blood. This is really important because medicines can affect each other, and understanding these interactions helps doctors prescribe them safely and effectively in the future. By studying healthy volunteers, researchers can get clear information about how the body handles these drugs without other health conditions getting in the way. It's a key step in developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

19 Jul 2023

Healthy volunteer trial

What is this study about?

This study is all about understanding how medicines interact with each other in the body. You might know that sometimes medicines can affect how other medicines work – they might make them stronger, weaker, or even cause unexpected side effects. Researchers need to carefully test these interactions before new drugs can be widely used.

In this particular study, they are looking at a new drug called BI 1810631 and a commonly used medicine called carbamazepine. Carbamazepine is a medication prescribed for conditions like epilepsy (which causes seizures) and some types of nerve pain. The study wants to see if taking carbamazepine changes the amount of BI 1810631 that stays in a person's blood. This is important information because if one drug changes the levels of another, doctors need to know so they can give the correct dose and avoid problems.

This kind of research is called a 'Phase 1' study. These are very early studies, usually done with healthy volunteers, to safely gather basic information about a new drug. The aim is not to treat an illness, but to learn how the body handles the new drug – how it's absorbed, distributed, broken down, and leaves the body, especially when another drug is present. The results from studies like this help scientists understand how new medications might work and how to use them safely in the future for people who need them.

Key takeaways

This study looks at how two specific drugs interact in healthy men.
It's a Phase 1 study, focusing on drug safety and how the body handles new medicines.
Participants will be closely monitored by medical staff.
The results help make future medicines safer and more effective.
You won't get treatment for a specific condition in this study.

Who may be eligible?

This study is specifically looking for healthy male volunteers. This means you should not have any serious ongoing health conditions or be taking many other regular medications.

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning men of any age 18 or over can be considered. The research team will do medical checks to make sure you are in good health before you can join.

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 male?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you willing to potentially take two different medications as part of the study?
Are you able to attend several clinic visits, possibly including overnight stays?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a screening visit to check your health and make sure you fit the study requirements. This would involve a medical history, physical exam, and some tests like blood and urine samples.

If you qualify, you would then attend a set number of study visits at the clinic. These visits would involve taking the study medications (BI 1810631 and carbamazepine), sometimes together and sometimes separately, according to a schedule. During these visits, the research team would closely monitor you, take regular blood samples to measure drug levels, and check your general health. You might also need to stay overnight at the clinic for some parts of the study. The total time you would be involved in the study, including all visits and any follow-up, would be fully explained by the study team, but these types of studies can sometimes last several weeks or a few months from start to finish.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A potential benefit of this study is that you would be contributing to valuable medical research, helping to understand new drugs and how they interact, which could lead to safer and more effective treatments for others in the future. There are no direct personal health benefits expected from participating in this particular study as you would be a healthy volunteer. Potential risks include side effects from the study drugs (which would typically be mild and temporary in early-phase studies, but the team would monitor you closely), discomfort or bruising from blood samples, and the time commitment required. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Germany

Common questions

What does 'healthy volunteer trial' mean?

It means the study is for people who generally don't have serious medical conditions and aren't taking lots of other medicines. This helps researchers understand how the new drug works without other health problems complicating the results.

What is carbamazepine?

It's a medicine commonly used to treat conditions like epilepsy (which causes seizures) and some types of ongoing nerve pain.

What is BI 1810631?

It's a new drug being investigated by researchers. This study is one of the first steps to learn more about how it works in people.

Will I get better if I join this study?

No, this study is for healthy volunteers and is not designed to treat an illness. The goal is to gather information about how drugs interact, not to improve your health.

How long will the study take?

The full duration, including screening, dosing periods, and follow-up, will be clearly explained by the study team. It can vary but might range from a few weeks to a couple of months from start to finish.