A Phase 1, Open-Label, Multiple-Part Trial to Evaluate the Drug-Drug Interaction Potential of PRAX-628 in Healthy Participants
This research is testing a new medicine, PRAX-628, which is being developed to help people with epilepsy. It's a very early-stage study, called a 'Phase 1' trial. This means we're only giving it to healthy adult volunteers, not people with epilepsy yet. The main goal is to understand how PRAX-628 might interact with other common medicines that people might take. By studying these 'drug-drug interactions', we can learn if PRAX-628 changes how other medicines work, or if other medicines change how PRAX-628 works. This information is really important for making sure the new medicine will be safe and effective when it's eventually given to patients with epilepsy. We want to find out as much as possible about it early on.
At a glance
What is this study about?
Imagine your body as a complex machine that processes medicines. When you take two different medicines, sometimes they can affect each other. One medicine might speed up or slow down how your body uses the other. This study is like a detective story, trying to figure out if our new medicine, PRAX-628, affects other common medicines, or if other medicines affect PRAX-628. We want to understand these interactions, which are called 'drug-drug interactions'.
PRAX-628 is a new medicine being developed for people who have epilepsy. Epilepsy is a condition that affects the brain and can cause seizures. Before a new medicine can be given to people with a condition like epilepsy, it needs to go through several careful testing stages. This study is one of the very first steps in that process.
Because this is such an early stage, we are testing PRAX-628 in healthy adult volunteers. This helps us learn about the medicine's basic behaviour in the body without the added complexity of a medical condition. The information we gather from this study will be used to help decide if PRAX-628 can safely move forward to larger studies, eventually involving people with epilepsy.
Key takeaways
- This is a very early study of a new medicine for epilepsy called PRAX-628.
- It's being tested in healthy adults only, not people with epilepsy.
- The main goal is to see how PRAX-628 interacts with other common medicines.
- This helps ensure the medicine will be safe if used with other drugs later on.
- Participation involves clinic visits, taking medicine, and regular health checks.
- Your health will be closely monitored throughout the study.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. We welcome both men and women to take part. This study is specifically for people who are generally healthy, meaning you shouldn't have any major ongoing health problems or illnesses.
We would also check if you are currently taking any other medicines, both prescription and over-the-counter, or even herbal remedies. This is because the study is all about understanding how PRAX-628 interacts with other drugs. Some existing medicines might make you unsuitable for the study, or you might need to stop taking them for a short time if it's safe to do so.
There will be other detailed health checks to make sure joining the study is safe for you. A doctor or nurse involved in the study will go through all the requirements with you and answer any questions you have.
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 regular clinic visits?
- Are you willing to take study medication and have blood tests?
- Are you willing to follow study rules carefully?
What does participation involve?
If you decide to take part, you'll be given the study medicine, PRAX-628, and possibly some other common medications to see how they interact. This will happen over several visits to a clinic. You might need to stay overnight at the clinic for some of these visits, or come in for several short appointments.
During your time in the study, doctors and nurses will closely monitor your health. They will take blood and urine samples regularly to see how your body is handling the medicines. They'll also check your vital signs like blood pressure and heart rate, and ask you about how you're feeling. The exact number of visits and the total length of time you're involved will be explained in detail before you agree to join. You'll always be informed about what's happening at each step.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is a 'Phase 1' study?
It's the first stage of testing a new medicine in humans, usually in healthy volunteers, to check safety and how the body handles the medicine.
Will I take an epilepsy medicine for my epilepsy?
No, this study is for healthy volunteers, not people with epilepsy. We are testing how the medicine interacts with other drugs in general.
What does a 'drug-drug interaction' mean?
It's when two medicines affect each other in your body, changing how they work or how your body handles them.
Will I be paid to take part?
Often, studies like this offer payment for your time and to cover expenses, but this would be confirmed by the study team.
What happens after this study?
If PRAX-628 is found to be safe and interact well with other drugs, it may move to later stages, testing it in people with epilepsy.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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