Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy people to test whether iclepertin has an effect on cardiac safety

This research study is looking for healthy volunteers to help us understand a new medicine called iclepertin. The main goal is to carefully check if this medicine has any effects on a healthy person's heart. This kind of early study, often called a Phase 1 study, is really important. It helps scientists learn how a new medicine works in the body and if it's safe, before it's given to people who are unwell. By taking part, you would be helping researchers gather vital information about iclepertin, which could eventually lead to new treatments for various health conditions. We'll be monitoring your health closely throughout the study to ensure your safety.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

24 Oct 2023

Healthy

What is this study about?

This study is designed to learn more about a new medicine called iclepertin. When new medicines are developed, we need to test them very carefully to make sure they are safe before they can be used to treat illnesses. This particular study is focusing on healthy people, which means people who don't have any major medical conditions.

The main thing we want to find out is whether iclepertin has any effects on the heart. We will use special tests to monitor your heart and see how it responds to the medicine. This is a very important step because understanding how a new medicine affects the heart is crucial for its safe development. We want to be absolutely sure that iclepertin doesn't cause any unexpected heart-related problems.

By taking part in this study, you would be contributing to medical research that could one day help many people. The information we gather will help researchers decide if iclepertin is safe enough to be tested in people who have specific health conditions, hoping it can become a helpful treatment in the future. Your health and safety will be our top priority throughout the study.

Key takeaways

This study is testing a new medicine called iclepertin in healthy people.
The main aim is to check if iclepertin affects the heart.
It's an early-stage study to gather important safety information.
You must be 18 or over and generally healthy to participate.
Your health will be closely monitored throughout the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adult volunteers. To be able to join, you must be at least 18 years old. There is no upper age limit, meaning older adults are also welcome to take part if they meet all the other requirements.

Critically, this study is only for people who are considered healthy. This means you shouldn't have any significant ongoing medical conditions. Both men and women are welcome to participate in this research.

The research team will carry out a thorough health check to make sure you are suitable for the study. This is to ensure your safety and that the study results are as clear as possible.

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 several clinic appointments?
Are you comfortable taking a new study medicine?
Do you understand that your heart will be monitored?
Are you a UK resident generally?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to attend several appointments at the study clinic. These visits will involve various health checks, such as blood tests, possibly urine tests, and having your heart monitored (for example, with an ECG, which measures your heart's electrical activity). You would also be given doses of the study medicine, iclepertin, usually in tablet form, according to a specific schedule.

Over the course of the study, the research team will closely monitor your health to see how your body reacts to the medicine and to check for any changes, especially concerning your heart. There will be follow-up appointments after you stop taking the medicine to make sure everything returns to normal. The exact number of visits and the total duration of your involvement will be explained to you in detail before you agree to participate.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A possible benefit is that you would be contributing to scientific knowledge that could lead to new treatments for others. You would also receive regular health check-ups and monitoring by medical professionals. Potential risks include feeling unwell from the study medicine, such as headaches, nausea, or other side effects, though the study aims to identify and understand these. There's also the time commitment required for clinic visits. Remember, your participation is completely voluntary, and you have the right 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 iclepertin?

Iclepertin is a new medicine that is being investigated by researchers. We don't know what it's for yet, but this study is helping us learn about its safety and how it works in the body.

Will I become unwell if I take part?

This study is designed to check for any effects of the medicine even in healthy people. We will monitor you very closely for any changes in your health, especially your heart, and will respond quickly if you feel unwell. The team will explain all known possible side effects.

Do I have to pay to take part?

No, you do not have to pay anything to take part in this research study. All study-related tests and medications will be provided free of charge.

Will I get paid for my time?

Often, studies like this offer some payment to cover your time, travel, and inconvenience. This will be fully explained to you by the study team, if applicable.

What kind of heart monitoring will be done?

The study team will explain the specific heart tests, but they will likely include electrocardiograms (ECGs) which measure the electrical activity of your heart, similar to what a GP might do.