Open label, single-center, cross-over randomized, relative bioavailability study comparing a new pitolisant hydrochloride tablet formulation at 4 different strengths versus the marketed pitolisant (Wakix®) tablet formulation after single oral administrations in healthy subjects
This research is looking at a new version of the medication pitolisant, which is used to treat narcolepsy, a condition that causes extreme daytime sleepiness. The study involves healthy adult volunteers and aims to compare how the new pitolisant tablets, in four different strengths, are absorbed and used by the body. They will be compared to the currently available Wakix® tablets. Participants will take both the new and old tablet versions at different times. This type of study, called a 'bioavailability' study, helps ensure that new drug formulations deliver the medication effectively and safely before they can be used by patients.
At a glance
What is this study about?
This study is about a medication called pitolisant, which is currently sold under the brand name Wakix®. Pitolisant is used to treat narcolepsy, a long-term brain condition that causes people to feel very sleepy during the day and can sometimes lead to sudden muscle weakness called cataplexy.
The main goal of this research is to test a new way pitolisant is made into a tablet. We want to see how well these new tablets, given at different strengths, are absorbed into the body compared to the version of Wakix® that's already available. This is important because even if the active ingredient is the same, how a tablet is made can affect how much of the medicine gets into your system and how quickly.
By understanding this, researchers can make sure that if the new tablet formulation is used in the future, it will work safely and effectively for patients. This is a very early stage study, often called 'Phase I', and involves healthy people rather than patients with narcolepsy, to understand the basic way the new drug formulation behaves in the body.
Key takeaways
- This study is testing a new tablet version of the narcolepsy drug, pitolisant (Wakix®).
- It's comparing how the new tablets are absorbed by the body versus the current ones.
- The study involves healthy adults aged 18 and older.
- Participants will try both the new and old tablet versions.
- It's an early-stage study to understand the drug's behaviour in the body.
- Full details of risks and benefits will be provided by the study team.
Who may be eligible?
To take part in this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome to participate. Being 'healthy' generally means you don't have any major ongoing medical conditions that might affect how the medicine works or put you at extra risk.
The study team will carry out some health checks to make sure it's safe for you to take part. This will likely include a review of your medical history and some simple tests. They will discuss any specific requirements with you in detail.
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 available to attend study visits at a single centre?
- Are you able to take oral medication?
- Are you comfortable with having blood samples taken throughout the study?
What does participation involve?
If you decide to take part, you'll be given both the new and the currently available pitolisant tablets at different times during the study. This is called a 'cross-over design', meaning each participant will try both types of tablets over the course of the study. You will take one dose of the medication at a time.
We anticipate that your participation will involve various visits to the study centre, where blood samples will be taken at different times after you've taken the medication. These blood samples help us understand how the drug is absorbed and eliminated from your body. There will also be health checks and monitoring throughout. The exact number of visits, tests, and the total duration of the study will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is pitolisant?
Pitolisant (brand name Wakix®) is a medication used to treat narcolepsy, a condition causing extreme daytime sleepiness.
Why is this study using healthy volunteers instead of patients?
This type of early study often uses healthy volunteers to safely understand how a drug is absorbed and processed by the body without the complications of an existing health condition.
What does 'bioavailability' mean?
Bioavailability refers to how much of a drug gets into your body's circulation and is available to have an effect.
Will I have to stay overnight at the study centre?
The study team will explain the specific schedule, including whether any overnight stays are required due to the timing of blood samples.
Will I be paid for taking part?
Compensation for time and travel expenses is often provided in studies like this. The study team will give you full details.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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