Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to learn more about how safe nurandociguat is and how it affects the way the body processes rosuvastatin and dabigatran in healthy adults

This study is designed to learn more about a new medicine called nurandociguat. It's a very early-stage study, which means it will be given to healthy adult volunteers, not people with a specific illness. The main goals are to check if the medicine is safe and how the body handles it. Researchers also want to see if nurandociguat changes the way your body processes other common medicines, specifically rosuvastatin (used to lower cholesterol) and dabigatran (a medicine that helps prevent blood clots). Understanding these interactions is a crucial step in developing new medicines, ensuring they can be used safely and effectively alongside other treatments in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer AG

Enrolment target

Start

09 Mar 2026

Chronic Kidney Disease

What is this study about?

Imagine your body as a clever chemical factory. When you take a medicine, your body works to use it and then get rid of it. This study is like sending a new product, nurandociguat, into that factory to see exactly what happens. We want to know if it's safe to use and how your body processes it. This is a very early stage of research, often called a 'Phase I' study, which means the medicine is being tested in healthy people for the very first time.

Researchers are particularly interested in how nurandociguat might interact with other medicines you might take. In this study, they're looking at rosuvastatin, which is often used to lower cholesterol, and dabigatran, a medicine that helps prevent blood clots. Sometimes, one medicine can affect how another medicine works in your body, either by making it stronger or weaker, or by changing how quickly your body gets rid of it. Understanding these interactions is really important for doctors to know if a new medicine is safe to give alongside other treatments.

Even though this study is about a new medicine, it's not directly treating any condition at this stage. It's a vital step in learning if this new medicine can be developed further to help people in the future, particularly those who might have conditions like chronic kidney disease, where carefully managing medicines is especially important. By studying healthy people first, we can gather crucial information before considering it for those who are unwell.

Key takeaways

It's a study for healthy adults aged 18 and over.
The main goal is to test the safety of a new medicine, nurandociguat.
Researchers will also check how nurandociguat interacts with rosuvastatin and dabigatran.
This is an early-stage study (Phase I) to learn basics about the medicine.
You won't be treated for a specific illness in this study.
Your participation helps to advance medical research for the future.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. Both men and women can take part.

As this is a study about understanding how medicines work, you generally wouldn't be able to join if you have a serious ongoing health condition, are taking many other medications, or have certain allergies. The study focuses on healthy volunteers to get a clear picture of how the new medicine behaves without other health issues complicating the results.

There will be specific health checks and tests done to make sure you are healthy enough to participate safely. The medical team will review your medical history carefully to ensure you meet all the requirements.

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 18 years old or older?
Are you generally in good health?
Are you able to attend regular clinic visits?
Are you not currently taking a lot of different medications?
Are you willing to take the study medicines as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the study medicine, nurandociguat, and at different times, you would also receive rosuvastatin and dabigatran. You would need to visit the study clinic regularly. These visits will involve various assessments, such as blood tests, urine tests, and checks of your vital signs (like blood pressure and heart rate) to see how your body is reacting to the medicines. The researchers will be closely monitoring you for safety.

The study will involve several visits over a period of time, and some visits might require you to stay at the clinic for a day or even overnight. Details about the exact number of visits, how long each visit will be, and the total duration of your involvement will be fully explained before you agree to join. You will be carefully monitored throughout your time in the study, and there will be follow-up appointments after you stop taking the study medicines to ensure you remain well.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical research that could help develop new medicines for the future. You will also receive careful medical monitoring throughout the study. However, like all medicines, nurandociguat could have side effects, which might be mild or, in rare cases, more serious. Taking rosuvastatin and dabigatran also carries their own known risks, which will be explained to you. You will be told about all the potential risks in detail before you decide to join. It's important to remember that you are free 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.

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Unverified
Germany

Common questions

What is nurandociguat?

It's a new medicine being studied. This research is about understanding how it works in the body and if it's safe, not to treat a health condition yet.

Why are healthy people needed for this study?

Using healthy volunteers allows researchers to clearly see how the new medicine affects the body without other health problems making the results harder to understand.

Will I get other medicines during the study?

Yes, you will also be given rosuvastatin (for cholesterol) and dabigatran (a blood thinner) at different times to see how they interact with nurandociguat.

Will this study help me if I have chronic kidney disease?

This particular study isn't designed to treat chronic kidney disease directly, but the information learned could help in developing future treatments for people with this condition.

How long will I be involved in the study?

The exact length of time will be explained by the study team, but it will involve several visits to the clinic, possibly including overnight stays.