Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A TQT Study to Investigate the Effect of Enpatoran on Cardiac Repolarization in Healthy Participants

This research study is about a new medicine called Enpatoran. We want to understand how it affects the electrical signals that control your heartbeat, specifically a part called 'cardiac repolarization.' Think of it like checking the rhythm and timing of your heart's electrical system after taking the medicine. We're looking for healthy adults, aged 18 and older, to take part. This is an early stage of testing new medicines in people, sometimes called Phase 1. The main goal at this stage is to make sure the medicine is safe and doesn't have unexpected effects on your heart. We're not treating any illness; we're just learning about the medicine itself.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Healthcare KGaA

Enrolment target

Start

17 Jul 2024

Healthy

What is this study about?

This study is an important step in developing new medicines. Whenever a new medicine is created, scientists need to carefully check how it behaves in the human body, especially its effects on vital organs like the heart. The main aim of this particular study is to see if a medicine called Enpatoran changes the heart's electrical rhythm, which is crucial for how your heart pumps blood.

Your heart has a very precise electrical system that makes it beat regularly. One part of this system is called 'repolarization,' which is basically the heart's electrical reset after each beat. If a medicine affects this reset, it could potentially cause problems with your heart rhythm. This study uses special heart tests to monitor these electrical signals very closely after participants take Enpatoran.

By carefully studying healthy volunteers, researchers can get a clear picture of whether Enpatoran has any impact on heart activity without other illnesses complicating the results. This information is vital for deciding if the medicine can be safely tested in people with specific health conditions in the future.

Key takeaways

This study is testing a new medicine called Enpatoran.
It aims to see if the medicine affects your heart's electrical activity.
Only healthy people aged 18 and over can join.
This is an early safety check for the new medicine.
Participation involves clinic visits and heart monitoring.
You will not be treated for an illness in this study.

Who may be eligible?

This study is looking for volunteers who are generally healthy. You need to be at least 18 years old to take part. There is no upper age limit, so people of many adult ages can participate.

Both men and women are welcome to join this study. The most important thing is that you are in good overall health, as confirmed by medical checks, because the study aims to understand how the medicine works in a typical, healthy body.

You would not be able to join if you have certain health conditions or are taking medications that could interfere with the study results or put your health at risk. The study team will review your medical history with you to ensure it's safe for you to take part.

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?
Do you consider yourself generally healthy?
Are you able to attend clinic visits?
Are you comfortable having blood tests and ECGs?
Are you willing to take an investigational medicine?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will typically attend a research clinic for several visits. These visits will involve various tests, including regular electrocardiograms (ECGs), which measure your heart's electrical activity. You'll likely have blood drawn occasionally to check how the medicine is processed by your body and to monitor your general health.

You will be given the study medicine, Enpatoran, usually on specific days. The study team will observe you closely after you take the medicine to see how you react. There might be some follow-up calls or visits after you've finished taking the medicine to ensure you remain well. The total duration of your participation will be explained to you in detail by the study team.

Potential risks and benefits

Taking part in any clinical study carries potential benefits and risks. You might not directly benefit from this study, as its main purpose is to gather information about a new medicine. However, you would be contributing valuable knowledge that could help others in the future. Potential risks could include side effects from the medicine, discomfort from blood tests or other procedures, or unforeseen reactions. All known potential risks will be thoroughly explained to you. You are free to withdraw from 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.

—
Unverified
Germany

Common questions

What is 'repolarization'?

It's the electrical 'reset' phase of your heart after each beat, getting it ready for the next one. We're checking if the medicine affects this reset.

Why only healthy people?

By studying healthy individuals, researchers can see the medicine's effects clearly, without other health conditions making it harder to understand.

Will I get paid for taking part?

This study information doesn't say, but many early-stage studies offer payment for your time and travel. You should ask the study team about this.

What is 'Phase I'?

Phase I is the first stage where a new medicine is tested in people. The main goal is to check its safety and how it works in the body.

What if I feel unwell during the study?

The study team will monitor you closely, and you should tell them immediately if you feel unwell at any time. Your safety is their priority.