Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Open label, single-center, cross-over randomized, relative bioavailability study comparing a new pitolisant hydrochloride tablet formulation versus the marketed pitolisant (Wakix®) tablet formulation after single oral administrations in healthy subjects.

This study is looking at a new version of a medication called pitolisant, which is currently sold as Wakix®. This medicine helps people with narcolepsy, a condition that causes extreme daytime sleepiness and sometimes sudden muscle weakness called cataplexy. In this study, healthy adult volunteers will try the new pitolisant tablet and compare it to the existing Wakix® tablet. The main goal is to find out if the new tablet is absorbed and works in the body in a similar way to the original, after taking just one dose. This type of research helps ensure that new versions of medicines are as effective as the ones already available.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bioprojet Pharma

Enrolment target

Start

06 Mar 2025

narcolepsy with cataplexy Narcolepsy

What is this study about?

This study is about a medication called pitolisant, which is sold under the brand name Wakix®. This medicine is used to treat narcolepsy, a condition where people feel very sleepy during the day and can sometimes experience sudden muscle weakness known as cataplexy.

The researchers have created a new way to deliver pitolisant – a new tablet formulation. The main purpose of this study is to compare this new tablet with the Wakix® tablet that is currently available. They want to see if, after taking a single dose, the new tablet acts in the body in a very similar way to the original tablet. This is important to make sure that any new version of a medicine works just as well and is absorbed similarly.

This kind of study is a very early step in testing a new medicine or a new version of an existing medicine. It helps scientists understand how the body handles the medicine before it's given to people who actually have narcolepsy. If the new tablet is found to be similar enough to the existing one, it could potentially offer another option for patients in the future.

Key takeaways

Tests a new version of an existing narcolepsy drug (pitolisant).
Compares the new tablet to the current Wakix® tablet.
Aims to see if both tablets work similarly in the body.
Involves healthy adults, aged 18 and over.
Participants will receive single doses of both tablets over time.
It's an early-stage study to gather basic information.

Who may be eligible?

This study is looking for healthy adults to take part. This means you should generally be in good health and not have any serious ongoing medical conditions.

You must be at least 18 years old to join this study. There is no upper age limit, so older adults are also welcome, as long as they meet the other health requirements.

Both men and women can participate in this research. The study will involve a health check to make sure it's safe for you to take part.

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?
Do you have no major ongoing medical conditions?
Are you available for multiple visits to a single clinic?
Are you comfortable with taking medication and having blood tests?

Answer every question to see your result.

What does participation involve?

If you join this study, it's called a 'cross-over randomized' study. This means you will receive both the new pitolisant tablet and the existing Wakix® tablet at different times, but you won't know which one you're getting first. Everything will be given by mouth, as a single tablet dose.

You will need to visit a single research site for your appointments. These visits will likely involve some health checks before you take the medication, and then closely monitoring your body after you've taken each tablet to see how the medicine works. This might include blood tests to measure the level of the medicine in your system. There will also be follow-up checks.

The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained to you before you agree to take part.

Potential risks and benefits

Potential benefits of taking part include contributing to medical research and helping develop new medication options for people with narcolepsy. While the medication is generally well-understood, there's always a chance of side effects, even in healthy individuals. You will be closely monitored, and all known risks will be explained. You have the right to withdraw from the study at any time, for any reason, without it affecting your future 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 narcolepsy?

Narcolepsy is a long-term brain condition that causes a person to fall asleep suddenly and unexpectedly during the day. It can also cause sudden muscle weakness called cataplexy.

What is pitolisant (Wakix®)?

Pitolisant is a medicine approved to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.

Why is this study using healthy people?

For very early studies like this (Phase I), healthy volunteers help researchers understand how a new medicine or a new version of a medicine behaves in the body without other health conditions making it complicated.

Will I get paid for taking part?

Sometimes studies offer payment or cover expenses for your time and travel. Ask the study team about this possibility.

Will I really take both the new and old tablets?

Yes, in a 'cross-over' study you will take both medicines at different times, which helps compare them directly in the same person.