Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Effect of itraconazole on the pharmacokinetics of a single oral dose of BI 1584862 in healthy male subjects (an open-label, two-period, fixed-sequence design study)

This study is investigating how a widely used antifungal medicine, itraconazole (often prescribed for fungal infections), interacts with a new experimental drug, BI 1584862. The main goal is to understand if taking itraconazole changes how the body absorbs and uses BI 1584862. Researchers will measure how much of the new drug enters the bloodstream and how long it stays there when itraconazole is also given. This type of study is important for developing new medicines responsibly, as it helps doctors understand how different drugs might interact, ensuring patient safety and effective treatment. This particular study only involves healthy male volunteers.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

08 Sep 2023

Healthy volunteer trial

What is this study about?

This research study is trying to understand how two medicines might interact when taken together. One medicine is called itraconazole, which is a common drug used to treat fungal infections. The other is a new study drug known as BI 1584862. Because different medicines can affect how well other medicines work in the body, it’s really important for scientists to study these interactions.

In this study, researchers will be looking at how the body handles the new study drug when itraconazole is also in the system. They want to find out things like how much of the new drug gets into your bloodstream and how quickly your body processes it. This information is key to making sure that if this new drug is ever approved for use, doctors will know the best and safest way to prescribe it, especially if patients are already taking other medications.

This is an early-stage study, meaning it’s one of the first human trials for BI 1584862. It’s being done with healthy volunteers, which helps researchers understand the basic effects of the drugs without the complications of other health conditions. The results from studies like this help build a strong foundation for future research.

Key takeaways

This study is testing how a new drug interacts with a common antifungal medicine.
It's an early-stage study involving healthy men.
The main goal is to see how much of the new drug enters the body and how quickly.
Participants will take both the new drug and the antifungal medicine.
This research helps ensure new medicines are prescribed safely in the future.
You have the right to leave the study at any time.

Who may be eligible?

This study is looking for healthy volunteers to take part. To be eligible, you must be an adult aged 18 years or older.

Crucially, this particular study is only open to men. Researchers will assess your overall health to make sure you are suitable and able to take part safely.

Being a 'healthy volunteer' means you generally don't have any significant ongoing medical conditions or take regular prescription medications that might affect the study results, beyond what the researchers themselves are administering.

Quick self-check

Are you 18 years old or older?
Are you male?
Do you consider yourself generally healthy?
Do you currently have any significant ongoing medical conditions?
Are you currently taking any regular prescription medications?

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 in this study, you would receive the new study drug, BI 1584862, orally (meaning you would swallow it). You would also receive itraconazole, which is a liquid medicine. The study is designed in two rounds (periods), following a set order.

During your time in the study, you would have blood samples taken at various times to allow researchers to measure the levels of the study drug in your body. This helps them understand how the drugs are absorbed and processed. You would also have regular check-ups to monitor your health and any effects of the medicines.

The exact number of visits, the duration of each visit, and the total length of your involvement in the study would be fully explained to you before you agree to participate. There will also be follow-up appointments to ensure your health remains good after you have completed taking the study medications.

Potential risks and benefits

Taking part in any research study has potential benefits and potential risks. A potential benefit could be contributing to medical knowledge that might help future patients. There is also the chance that you might experience side effects from the study medications. However, the study is designed with your safety in mind, and you will be closely monitored by medical professionals. 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 'BI 1584862'?

BI 1584862 is an experimental medicine that is being studied. It is not currently available for public use.

What is itraconazole?

Itraconazole is a common medicine used to treat various types of fungal infections in the body.

Why is this study only for men?

Early-stage studies sometimes limit participation to a specific group (like men or women) to simplify the initial research and understand the drug's basic effects without all possible variables.

What does 'healthy volunteer' mean?

Being a healthy volunteer usually means you don't have any major medical conditions, and you are not taking other medicines that could interfere with the study drugs. Doctors will check your health carefully.

Will I get paid for taking part?

The study design shared doesn't mention payment. It's common for clinical trials to offer compensation for time and travel, but you should ask the research team directly about this.