Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Randomized, Double-Blind, Placebo and Positive-Controlled Crossover Study to Evaluate the Effect of Clinical and Supraclinical Doses of GEH200486 0.5 M Injection on the Thorough QT/QTc in Healthy Volunteers.

This research study is investigating a new medication, GEH200486. We're particularly interested in how different amounts of this medicine might affect your heart's electrical activity, specifically something called the QT interval, which is like your heart's charging and re-charging time. This is a very early-stage study, designed for healthy volunteers aged 18 and older, both men and women. Participants will receive the new medicine, a dummy treatment (placebo), or a known medicine, at different times. By doing this, we can carefully compare how GEH200486 works. The main goal is to check its safety and see how it behaves in the body before it can be tested in patients who might need it. Your participation helps us learn vital information about new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

GE Healthcare Limited

Enrolment target

Start

31 Jul 2023

Healthy volunteers

What is this study about?

This study is about a new medicine called GEH200486. When new medicines are developed, we need to understand exactly how they work in the body and, most importantly, if they are safe. One crucial thing we always check is how medicines might affect your heart. Your heart has a natural electrical rhythm that keeps it beating regularly. This study specifically looks at a part of this rhythm called the QT interval. It's like measuring how long your heart takes to "recharge" between beats. Changes in this interval can sometimes be a sign of a heart problem, so it's a very important safety check for any new medication.

In this early research, we're asking healthy volunteers to take part. This is important because healthy people can help us understand the basic effects of the medicine without worrying about their existing health conditions complicating the results. We will be giving different doses of GEH200486, including doses that are a bit higher than what might be used in patients. This helps us to fully understand its effects, even at stronger levels.

The information we gather from this study is vital. It helps us decide if GEH200486 is safe enough to be tested further in people who actually need treatment for a specific illness. Think of it as laying the groundwork for future medical advances. Your involvement is a key step in bringing new, safe, and effective medicines to patients.

Key takeaways

This study is testing a new medicine called GEH200486.
It's checking how the medicine affects your heart's electrical rhythm, for safety.
The study needs healthy adult volunteers, aged 18 and older, both men and women.
Participants will receive the new medicine, a placebo, or a comparison medicine.
Your involvement helps pave the way for new medicines to be developed.
Careful monitoring and regular checks will be a key part of your participation.

Who may be eligible?

This study is looking for healthy people to take part. This means you should generally be in good health and not have any serious medical conditions that might affect how the medicine works or make your participation unsafe.

To join this study, you must be at least 18 years old. There's no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part in this research.

Beyond these basic requirements, there will be more detailed checks to make sure the study is a good fit for you. These will usually include a medical check-up, some blood tests, and checking your heart's electrical activity (an ECG), to ensure you are truly healthy enough for the study.

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 several clinic visits, possibly with overnight stays?
Are you comfortable with regular medical checks, including ECGs and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the clinic several times. During these visits, you'll receive the study medication (GEH200486), or a "dummy" treatment (placebo), or a known medicine that helps us compare the effects. You might stay overnight in the clinic for some visits. During your time in the study, medical staff will frequently check your heart's electrical activity using an ECG, and you'll have blood and urine samples taken regularly. These tests help us see how the medicine is affecting your body. The study is designed as a 'crossover' study, which means you'll likely receive different treatments at different times, with a break in between, so we can properly compare them. The total duration of your involvement, including all visits and follow-ups, will be explained in detail.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit is contributing to medical science and helping develop new medicines. While GEH200486 is a new medicine, it has undergone early safety checks. Possible risks include side effects from the medication, which could range from mild discomfort to more serious reactions. The study team will closely monitor you and explain all known risks. Remember, you have the right 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.

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Unverified
Netherlands

Common questions

What does 'Phase 1' mean for this study?

Phase 1 means this is one of the very first times this new medicine is given to people. It's mainly to check its safety and how it works in the body, usually in healthy volunteers.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active drug. It helps us see the true effects of the actual medicine.

What is the 'QTc' it mentions?

The QTc is a measurement of your heart's electrical activity. It tells us how long your heart takes to 'recharge' between beats. The study checks if the medicine changes this.

Will I know if I'm taking the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study team will know who is getting which treatment. This helps make the results fair and unbiased.

Will I get paid for taking part?

Payment for your time, travel, and inconvenience is common in Phase 1 studies. The study team will provide full details about any compensation.