Active not recruitingPHASE1INTERVENTIONAL

A Trial to Investigate the Safety and Pharmacokinetics of GRT6019 in Healthy Male Participants

We are conducting a study to learn more about a new medicine called GRT6019. This medicine is being developed to potentially help people with a condition called Duchenne Muscular Dystrophy (DMD). In this early-stage (Phase 1) study, we want to find out if GRT6019 is safe and well-tolerated when given to healthy men. We’re also interested in understanding how the body handles the medicine – how it's absorbed, used, and removed. This study will involve healthy male volunteers taking different doses of GRT6019 in a hospital setting and then at home, over several weeks, with health checks along the way. This information is key for future studies to see if GRT6019 can help people with DMD.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Grünenthal GmbH

Enrolment target

Start

06 Jan 2026

Estimated completion

01 Jun 2026

Duchenne Muscular Dystrophy (DMD)

What is this study about?

This study is about a new medicine called GRT6019. It's being developed as a potential treatment for Duchenne Muscular Dystrophy (DMD), a serious muscle-wasting condition. Since GRT6019 is a new medicine, we first need to make sure it's safe for people to take. That's why we're inviting healthy adult men to take part in this initial study. We want to understand how the medicine behaves in the body, such as how much gets into the bloodstream and how long it stays there, without any health conditions that might change test results.

This is what's called a 'Phase 1' study. In this phase, we usually test a new medicine on a small number of healthy volunteers. The main goal is to check for any side effects and to learn about the right doses. This helps us ensure that future studies, involving people with DMD, can be done as safely as possible. We are not expecting these healthy volunteers to get any health benefits from taking the medicine, as they don't have DMD. The purpose is purely to gather important safety and dosing information.

The information we collect from this study is really important. It will help researchers decide if and how to continue developing GRT6019. If it proves safe and we understand how it works in healthy people, it can move on to later stages of testing where it would be given to people who actually have Duchenne Muscular Dystrophy. This is a crucial step in trying to bring new treatments to those who need them.

Key takeaways

This study is looking at a new medicine for Duchenne Muscular Dystrophy (DMD).
It's a 'Phase 1' study, meaning we're checking safety and how the medicine works in healthy men.
GRT6019 is the new medicine being tested.
Healthy men aged 18-55 are needed.
The study involves a 2-week clinic stay and then home treatment with follow-up appointments.
Participants will not directly benefit from the medicine, but will help future patients with DMD.

Who may be eligible?

To join this study, you must be a man between 18 and 55 years old. You need to be generally in good health. This means a doctor will check your medical history, do a physical exam, and run some basic tests like blood pressure, heart trace (ECG), and blood tests to make sure you're well enough and that taking part won't put your health at risk. You also need to be able to understand what the study involves and agree to follow all the rules.

There are also some reasons why you might not be able to join. For example, if you have any major ongoing health problems with your heart, lungs, liver, kidneys, or stomach, you likely won't be suitable. If you've had a big operation recently (in the last 3 months) or are expecting to have one soon, you wouldn't be able to take part. Also, if you regularly take any medicines, including herbal remedies or over-the-counter painkillers, or if you're already in another medical study, you might not be eligible. This is to make sure the results are clear and that it's safe for you.

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 a man between 18 and 55 years old?
Are you generally healthy, with no major ongoing medical conditions?
Do you take any regular prescription, over-the-counter, or herbal medicines?
Have you had any major surgery in the last 3 months or expect to have one soon?
Are you able to stay in a clinic for 2 weeks?
Are you currently participating in another medical research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for about 10 weeks in total. First, there's a screening period of up to 4 weeks where doctors will check if you're suitable. If you are, then you'll enter the treatment period, which lasts 4 weeks. For the first 2 weeks of this period, you will stay in a clinic or hospital so doctors can closely monitor how your body reacts to the medicine called GRT6019. For the remaining 2 weeks of the treatment period, you'll be able to go home, but you'll still need to take the medicine as instructed and attend outpatient appointments. After you've finished taking the medicine, there will be a 5-week follow-up period with further check-ups to make sure you're well and to gather final information.

Potential risks and benefits

As with any medical study, there are potential benefits and risks. For healthy volunteers, the main benefit is contributing to medical research that could eventually help people with Duchenne Muscular Dystrophy. However, you will not receive direct health benefits yourself. Potential risks include experiencing side effects from the study medicine, which could be mild or, in rare cases, more serious. All procedures, like blood tests, also carry small risks. You will be closely monitored by medical staff throughout the study. Remember, taking part is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Biotrial Clinical Pharmacology Unit
Verified postcode
Rennes, France

Common questions

What is Duchenne Muscular Dystrophy (DMD)?

DMD is a serious genetic condition that causes muscles to become weak and waste away over time. It mainly affects boys.

Why are you testing this medicine on healthy men first?

Because GRT6019 is new, we need to first check if it's safe and how the body handles it in healthy people before giving it to patients with DMD.

Will I get better if I join this study?

No, as a healthy volunteer, you won't get any health benefits from taking GRT6019, as you don't have the condition it's designed to treat.

What does 'Phase 1' mean?

Phase 1 is the first stage of testing a new medicine in people. It mainly focuses on safety and understanding how the medicine works in the body.

How long will I be in the clinic for?

You will need to stay in the clinic for 2 weeks during the treatment period to be closely monitored after taking the medicine.