Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

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

This research study is for healthy male volunteers. It aims to understand how two medicines, bosentan and nerandomilast, interact when taken together. Researchers want to see if bosentan affects how much nerandomilast stays in the blood. This type of study is called a 'pharmacology' study and is one of the very first steps in testing a new medicine or understanding how existing ones work together. It's not about treating a specific illness, but about learning how these medicines behave in the body. This information is important for doctors and scientists to know how to safely use these medicines in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

01 Jul 2025

Healthy volunteer trial

What is this study about?

This study is looking into how two different medicines, bosentan and nerandomilast, behave in the body when they are taken by healthy men. Specifically, the researchers want to find out if taking bosentan changes the amount of nerandomilast that stays in the blood.

Imagine your body as a processing plant for medicines. When you take a medicine, your body absorbs it, uses it, and then gets rid of it. Sometimes, taking one medicine can affect how your body processes another medicine. This study is designed to explore if bosentan has this kind of effect on nerandomilast.

This kind of research is very important for several reasons. By understanding how these medicines interact, doctors can make sure they prescribe them safely and effectively in the future, knowing if dosage adjustments might be needed. It's a foundational step in understanding how medicines work together within the human body.

Key takeaways

It's for healthy male volunteers.
The study looks at how two specific medicines interact in the body.
It's a very early-stage study to gather basic information.
Participation involves taking medicines and giving blood samples.
It's not about treating a disease, but about understanding medicine interactions.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You'll need to be at least 18 years old – there's no upper age limit mentioned.

To be considered healthy, you would generally not have any long-term medical conditions and would not be taking regular medication for an illness. The research team will do medical checks to make sure you are suitable for the study before you can take part.

Quick self-check

Are you a man?
Are you 18 years old or older?
Are you generally healthy, without any serious ongoing medical conditions?
Are you not currently taking a lot of different medications regularly?

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, you would receive the medicines being studied. The researchers would then regularly take blood samples to measure the levels of nerandomilast in your body. This helps them see how bosentan might be affecting it. There would likely be several visits to the study clinic for these measurements over a set period. Details about the exact number of visits, how long each visit lasts, and the total time you would be involved in the study would be fully explained before you agree to take part.

Potential risks and benefits

Potential benefits of taking part in this study include contributing to medical science, which helps us understand medicines better for future patients. You might also receive free health checks. All medicines have potential side effects, and while participants in this study are healthy, there's always a chance of experiencing side effects from the study drugs. The research team will carefully explain all known risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Germany

Common questions

What is the main goal of this study?

The main goal is to see if one medicine (bosentan) changes the amount of another medicine (nerandomilast) in the blood of healthy men.

Who can take part in this study?

Only healthy men who are 18 years old or older can take part.

Will I be given treatment for an illness?

No, this study is for healthy volunteers, not for treating any specific illness.

What will I have to do if I join?

You will take the study medicines and have blood samples taken regularly to check medicine levels.

Is it safe to take part?

All studies have potential risks, but researchers take care to ensure safety. All known risks will be fully explained to you before you decide to join.