AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy men to test how bosentan influences the amount of zongertinib in the blood

This study is a research project designed to understand how certain medicines interact. Specifically, it's looking at how a drug called bosentan affects the levels of another drug, zongertinib, in the blood. Researchers are seeking healthy men, aged 18 and older, to take part. This type of study, often called a 'Phase I' trial or 'human pharmacology' study, is an early step in testing new drugs or drug combinations. By understanding how these medicines might influence each other, scientists can learn more about how to use them safely and effectively in the future, particularly if a patient needs to take both at the same time. Volunteers will be carefully monitored throughout the study.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

15 Apr 2026

Healthy volunteer trial

What is this study about?

This study is a research project focusing on how two medicines, bosentan and zongertinib, behave when they are taken together in the human body. We know that different medicines can sometimes affect each other's actions, and understanding these interactions is really important for patient safety.

In this research, we want to see if bosentan changes the amount of zongertinib that stays in your blood. If bosentan causes the amount of zongertinib to go up or down, it could change how effective or safe zongertinib is. This kind of research is an early step in drug development and helps scientists understand how to best use these medicines if a person needs to take both of them.

By taking part, healthy male volunteers will help scientists gather important information. This information is crucial for doctors and pharmacists to understand potential drug interactions, which ultimately helps them prescribe medicines more safely and effectively for future patients. It’s all part of ensuring medicines work well and cause as few problems as possible.

Key takeaways

Tests how two medicines (bosentan and zongertinib) interact in healthy men.
Aims to understand how one medicine affects the blood levels of another.
Requires healthy male volunteers, aged 18 years and above.
Involves taking study medicines and having blood tests.
Helps improve medicine safety and effectiveness for future patients.

Who may be eligible?

This study is looking for healthy men to take part. To be eligible, you must be at least 18 years old. There is no upper age limit for participants.

As this is a 'healthy volunteer' study, you should generally be in good health. The research team will conduct careful checks to make sure participating is suitable and safe for you.

Quick self-check

Are you male?
Are you 18 years old or older?
Are you generally in good health?
Are you willing to take study medications?
Are you able to attend clinic visits?

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 will be asked to visit the study clinic regularly. During these visits, you will likely have blood samples taken to measure the levels of zongertinib in your blood after you have taken the study medications. You will be given bosentan and zongertinib as part of the study plan. The research team will explain exactly how and when to take these medicines.

Depending on the study plan, you might also have other health checks such as a physical examination, heart tests, or questions about your general well-being. The total length of your participation, including all visits and follow-up, will be clearly explained to you before you agree to join. You will be given a detailed schedule outlining everything involved.

Potential risks and benefits

Participating in research studies like this can help advance medical understanding, which may benefit future patients. You might also receive free health checks during your participation. However, there are potential risks, including side effects from the study medicines, discomfort from blood tests, or unforeseen reactions. You will be fully informed of all known potential risks before deciding to take part, and 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 the main goal of this study?

The main goal is to find out if one medicine (bosentan) changes how much of another medicine (zongertinib) is in the blood of healthy men.

Who can take part in this study?

Healthy men aged 18 years and older can take part. You will need to be in good general health.

Will I have to take any medicine?

Yes, you will be given bosentan and zongertinib as part of the study to see how they interact.

What does a 'healthy volunteer study' mean?

It means the study is looking for people who are generally well and don't have any specific health conditions that might affect the study results.

How long will I be involved?

The study team will tell you the exact duration of your involvement, including how many visits you'll need to make.