Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Bioavailability study of stiripentol after single oral administration of two different formulations (capsule and oral suspension) in 24 healthy subjects

This research study is about a medicine called stiripentol, which is used to help people with a severe type of epilepsy called Dravet syndrome. This particular study is in its very early stages, focusing on healthy volunteers rather than patients. Researchers want to understand how stiripentol is absorbed into the body when taken in two different forms: as a capsule and as a liquid. They will give a single dose of each form to healthy adults and measure how much of the medicine gets into their bloodstream. This helps them work out the best way to give the medicine for future use. It's a key step in developing new or improved treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Biocodex

Enrolment target

Start

10 Apr 2025

Dravet syndrome

What is this study about?

This study is designed to understand more about a medicine called stiripentol. Stiripentol is an important treatment for a very serious type of epilepsy called Dravet syndrome. Before any medicine can be widely used, scientists need to know exactly how it behaves in the human body. This includes how well it's absorbed, how quickly it starts to work, and how long it stays in the system.

In this particular study, researchers want to compare two different ways of taking stiripentol: as a capsule and as a liquid medicine. They're trying to find out if one form is absorbed better or more consistently by the body than the other. This information is crucial because it helps doctors and pharmacists decide the most effective way to give the medicine, ensuring patients get the right amount at the right time.

This is a very early stage study, often called a 'Phase I' study. It involves healthy volunteers, not people with Dravet syndrome. This is a common and important first step when testing new medicines or new ways of giving existing medicines. It helps ensure the medicine is safe and that scientists understand its basic behaviour in the body before it's given to patients who need it most.

Key takeaways

This study looks at how an epilepsy medicine (stiripentol) is absorbed.
It compares capsules versus a liquid version of the medicine.
Healthy adult volunteers, aged 18 and over, are needed.
The findings could lead to better ways of giving the medicine to patients.
Participation involves single doses of the medicine and blood tests.

Who may be eligible?

To be able to take part in this study, you would need to be an adult, aged 18 years or older. There is no upper age limit for joining.

Both men and women are welcome to take part in this study. The researchers aim to include a diverse group of participants to get a good understanding of how the medicine works.

Because this is a study looking at how the medicine is absorbed in generally healthy people, you would need to be in good overall health. The research team will do some checks to make sure you're suitable and that taking part would be 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 18 years old or older?
Are you generally in good health?
Are you a man or a woman?
Are you able to attend clinic visits?
Are you able to give blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of stiripentol in two different ways at different times – once as a capsule and once as a liquid. You would not get both at the same time. The study will involve several visits to a clinic for health checks and to provide blood samples. These samples will help the researchers measure how much of the medicine is in your body and for how long. You would have regular check-ups to monitor your health throughout your time in the study. The total duration of your participation, including all visits and follow-up, would be made clear to you before you start.

Potential risks and benefits

Taking part in this study could help advance our understanding of how stiripentol works, which might lead to better treatments for people with Dravet syndrome in the future. However, there are no direct health benefits for you as a participant. Like all medicines, stiripentol can have side effects, and you might experience some discomfort from blood tests. The study team will explain all known side effects and risks involved. You are free 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
France

Common questions

What is Dravet syndrome?

Dravet syndrome is a very severe form of epilepsy that usually starts in babies and young children, causing frequent and long-lasting seizures.

Why are healthy people taking part in this study?

Early-stage studies often use healthy volunteers to safely learn how a new medicine is absorbed and handled by the body before giving it to patients.

Will I be given the actual epilepsy medicine?

Yes, you will be given stiripentol, the medicine used for Dravet syndrome, but only a single dose at a time.

What does 'bioavailability' mean?

Bioavailability means how much of a medicine is absorbed into your bloodstream and becomes available to have an effect in your body.

Is this a new medicine?

Stiripentol is an existing medicine. This study is looking at different ways of giving it (capsule vs. liquid) rather than developing a new drug.