Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Open-Label Study to Investigate the TARP-ɣ8 Receptor Occupancy of RAP-219 Using a TARP-γ8 PET Tracer in Healthy Adult Participants

This is an early-stage study, called a Phase 1 trial, looking into a new medicine named RAP-219. The main goal is to understand how this medicine behaves in the body, specifically how it interacts with something called the TARP-γ8 receptor in the brain. Researchers are using a special scan, a PET scan, to see how much of the medicine reaches and attaches to this target. This study is being done in healthy adult volunteers, not people with a specific illness. This helps scientists safely learn about the medicine's basic actions and effects before trying it in patients. The information gathered from this study could be important for developing new treatments for conditions like epilepsy.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Rapport Therapeutics Inc.

Enrolment target

Start

27 May 2024

Epilepsy

What is this study about?

This study is a very early step in developing a new medicine called RAP-219. Think of it like testing a brand new car prototype before it goes into full production. In this case, we're not testing the car for speed or efficiency yet, but simply checking if all the basic parts work as expected and understanding how it functions.

The main purpose is to see how RAP-219 interacts with a specific part of your brain called the TARP-γ8 receptor. Scientists believe that by targeting this receptor, it might be possible to help people with conditions like epilepsy. To see this interaction, participants will undergo special scans, similar to an X-ray but more detailed, which can show where the medicine goes in the body.

Because this is such an early study, it's being done in healthy adult volunteers, not people who have epilepsy. This is a common and important step in medicine development to ensure safety and learn about the medicine's basic actions without interference from an illness. The results will help researchers decide if RAP-219 has the potential to become a useful treatment for epilepsy or similar conditions in the future.

Key takeaways

This is an early-stage study for a new medicine called RAP-219.
It aims to understand how the medicine works in the brain.
Healthy adult volunteers aged 18 and over are needed.
Special scans (PET scans) will be used to observe the medicine's effect.
This research could help develop future treatments for epilepsy.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged at least 18 years old. There's no upper age limit mentioned.

Both men and women are welcome to participate in this research. The study hasn't specified any other health requirements, but generally, early-stage studies like this look for people who are in good overall health.

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 a man or a woman?
Are you comfortable with attending multiple clinic visits?
Are you comfortable with receiving a new, untested medicine?
Are you comfortable with undergoing special brain scans (PET scans)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be one of the first people to try this new medicine. You would likely visit the study clinic several times for health checks, to take the study medicine, and to have special scans. These scans, called PET scans, involve a small amount of a harmless tracing substance that helps doctors see where the medicine goes in your body. There would also be follow-up appointments to make sure you're feeling well and to check on any effects of the medicine. The total duration for how long you'd be involved isn't specified but usually, early-stage studies like this last a few weeks to a couple of months.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of this study is helping advance medical science, possibly leading to new treatments for conditions like epilepsy in the future. However, because this is a new medicine, there might be side effects that are not yet known. These will be carefully monitored, and doctors will explain all known or potential risks to you before you decide to join. Remember, you can always change your mind and withdraw from the study at any time, for any reason, without affecting your regular 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
Belgium

Common questions

What is a Phase 1 study?

A Phase 1 study is the very first step where a new medicine is given to people. It's mainly to check if it's safe and to understand how it works in the body.

Why are healthy people needed for this study?

Using healthy volunteers helps researchers learn about the medicine's effects and safety in a controlled way, without other health conditions making things complicated. It's a crucial first step.

What is a PET scan?

A PET scan is a special type of imaging scan that helps doctors see how your organs and tissues are working. In this study, it helps track the medicine in your brain.

Will I receive the new medicine?

Yes, if you qualify and choose to participate, you would receive the new medicine, RAP-219, as part of the study.

Will I be paid to take part?

Studies often offer some payment for your time and travel, but this information isn't given here. You should ask the study team if this is available.