Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy men to compare the amount of vicadrostat and empagliflozin in the blood when taken separately and together

This research study is for healthy adult men. Its main purpose is to understand how two different medicines, called vicadrostat and empagliflozin, are processed by the body. Specifically, the researchers want to measure the levels of each medicine in the blood. They will compare what happens when these medicines are taken one at a time versus when they are taken together. This type of study, often one of the first human trials, helps scientists learn important information about how new medicines work and interact in the body before they are tested in larger groups of people who have specific health conditions. It's an important step in developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

16 Jun 2025

Healthy volunteer trial

What is this study about?

This study is designed for healthy men and is called a 'Human Pharmacology' or 'Phase I' trial. This means it's one of the very first times a medicine is tested in people. The main goal here isn't to treat a disease, but rather to learn how the medicines, vicadrostat and empagliflozin, are handled by the body. Researchers will be looking at how much of each medicine gets into your blood.

You might be wondering why this matters. When medicines are developed, it's really important to know how they behave. For example, if two medicines are often used together for a certain condition, doctors need to know if they interact in a way that changes how much of each medicine is in the body. If the levels change too much, it could affect how well the medicine works or even increase the chance of side effects.

By carefully measuring the levels of vicadrostat and empagliflozin in the blood when taken alone and when taken together, scientists can get a clearer picture of any potential interactions. This information is a crucial step in understanding whether these medicines can be safely and effectively used together in the future for patients who might need both.

Key takeaways

This study is for healthy adult men.
It checks how two medicines, vicadrostat and empagliflozin, interact in the body.
Participants will have regular health checks and blood tests.
This is an early stage of medicine development.
Your involvement helps improve future treatments for others.

Who may be eligible?

This study is looking for healthy men to take part. To be considered, you must be an adult, aged 18 years or older. There is no upper age limit, so older men can also participate.

Because this is a study for healthy volunteers, you should not have any serious ongoing health conditions. The research team will do careful checks to make sure you are in good health before you can join the study. They want to make sure it's safe for you to take part and that your health won't interfere with the study results.

Further checks will be carried out to make sure other specific health requirements are met.

Quick self-check

Are you a man?
Are you 18 years old or older?
Are you generally in good health?
Do you not have any serious ongoing medical conditions?

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'll first go through a screening process to check if you are healthy enough for the study. This will involve health checks and possibly blood tests. If you qualify, you will receive the study medications (vicadrostat and empagliflozin), either separately or together, over different periods.

Throughout the study, you will have regular visits to the clinic where the research team will monitor your health, take blood samples to measure the medicine levels, and check for any side effects. The exact number of visits and the overall duration of your participation will be explained in detail by the study team, but typically, these early phase studies can involve multiple visits over several weeks.

Potential risks and benefits

Taking part in any study has both potential benefits and risks. For this study, a direct health benefit for you is unlikely, as you are a healthy volunteer. However, you would be helping contribute to valuable medical knowledge that could benefit many people in the future. Potential risks include possible side effects from the medicines, discomfort from blood tests, and the time commitment required. All potential risks will be fully explained to you before you agree to participate, and you will 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 see how two medicines, vicadrostat and empagliflozin, behave in the body when taken alone and together in healthy men.

Who can take part in this study?

Healthy men aged 18 years and older can take part.

Will I receive treatment for a health condition?

No, this study is for healthy volunteers and is not designed to treat any health conditions.

What will I have to do if I join?

You'll have health checks, take the study medicines, and attend clinic visits for monitoring and blood tests.

Is there any cost to me to participate?

Generally, there is no cost to participants in clinical trials. Travel expenses may be covered, but you'd need to confirm this with the study team.