Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Evaluation of the Effect of Food, Itraconazole, and Rifampicin on the Single-Dose Pharmacokinetics of Naronapride.

This study looks at a new medicine called Naronapride, which is still in its early stages of development. We're trying to understand how the body handles this medicine. Specifically, we want to see if eating food changes how Naronapride works, and also if taking it with other common medicines (like Itraconazole or Rifampicin, which are used for fungal infections and some bacterial infections respectively) has an impact. Because this is a very early study, we're inviting healthy volunteers to take part. The information we gather will help researchers decide the best way to give Naronapride to patients in the future, making sure it works as safely and effectively as possible.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Dr. Falk Pharma GmbH

Enrolment target

Start

21 Aug 2025

No medical condition.

What is this study about?

This study is a very early stage of research, sometimes called a Phase 1 study. Its main goal is to carefully examine how a new medicine, called Naronapride, behaves inside the human body. Think of it like trying out a new recipe for the first time – you want to know how it reacts to different ingredients or cooking methods.

Specifically, researchers want to see if having food in your stomach changes how your body takes in, uses, and gets rid of Naronapride. They also want to understand if taking Naronapride at the same time as other commonly used medicines, such as Itraconazole (often used for fungal infections) or Rifampicin (used for some bacterial infections), affects how Naronapride works. This is important information because many people take more than one medicine, and doctors need to know how they might interact.

The findings from this study will help scientists understand the best conditions for Naronapride to work effectively and safely in the future. It’s about building a strong foundation of knowledge for this new medicine before it can be studied in people who have health conditions. This research is crucial for ensuring that when Naronapride eventually becomes available, it can be prescribed and used in the safest and most effective way possible.

Key takeaways

This is an early study of a new medicine called Naronapride.
It helps understand how Naronapride works in healthy people.
Researchers will check how food and other medicines affect Naronapride.
You must be at least 18 years old and in good health to participate.
Participation involves taking the medicine and having regular tests.

Who may be eligible?

This study is looking for healthy adult volunteers to participate. You need to be at least 18 years old – there’s no upper age limit, as long as you're in good health.

Both men and women are welcome to join. You don't need to have any specific health condition to be part of this research, as the aim is to see how the medicine works in a healthy person's body.

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 comfortable with blood tests and medical monitoring?
Are you able to attend clinic visits as required?
Are you willing to potentially take Naronapride with other medicines?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be taking a single dose of the study medicine, Naronapride. Researchers will then closely monitor your body's response, which will involve regular blood tests to check how the medicine is processed. You may also be asked to take one of the other medicines (Itraconazole or Rifampicin) at different times, or to take the study medicine with or without food, to see how these factors change things. The total duration of your involvement will depend on the specific group you are in, but it will involve multiple visits to the clinic, possibly including overnight stays, for observations and tests.

Potential risks and benefits

Taking part in any medical study carries some potential risks, like side effects from the study medicine or discomfort from blood tests. However, the study medicine has been tested in labs, and this initial human study is carefully controlled. There may not be a direct personal health benefit for you from participating, as this study is for gathering information, not to treat an illness. The benefit is to future patients by helping doctors understand this new medicine better. Remember, you can choose to leave 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
Portugal

Common questions

What is Naronapride?

Naronapride is a new medicine that researchers are developing. This study aims to understand how it works in the body.

Why is this study looking at healthy people?

Because it's an early-stage study, researchers first need to understand how the medicine works in people without other health conditions, before giving it to those who are ill.

Will I receive treatment for an illness?

No, this study is not designed to treat an illness. It's purely for gathering information about how Naronapride acts in the body.

Do I have to take other medicines during the study?

Yes, to see how Naronapride interacts, you might be asked to take it with other common medicines like Itraconazole or Rifampicin.

How long will my participation last?

The study involves a single dose of Naronapride, but you will have visits or stays to monitor how your body handles it. The exact duration will be explained by the study team.