Open label, single-center, cross-over randomized, relative bioavailability study comparing 4 new BF2.649 (pitolisant) tablet formulations versus the reference pitolisant (Wakix®) tablet formulation after single oral administrations in healthy male subjects.
This research study is looking at several new variations of a medication called pitolisant. Pitolisant is currently used to treat narcolepsy, a condition that causes extreme daytime sleepiness and sometimes sudden muscle weakness (cataplexy). The main goal of this study is to compare how well these new tablet formulations are absorbed into the body compared to the version of pitolisant that is currently available (known as Wakix®). Healthy male volunteers will take different forms of the drug at different times. This will help scientists understand if the new tablets are absorbed in the same way, which is important for making sure they work effectively and safely for future patients. This is an early-stage study, focusing on understanding the drug itself.
At a glance
What is this study about?
This study is comparing different new forms of a medicine called pitolisant. Pitolisant is a drug that helps people who have narcolepsy. Narcolepsy is a condition that can make people feel extremely sleepy during the day, even when they've had enough sleep. Some people with narcolepsy also experience 'cataplexy', which is a sudden, temporary loss of muscle tone, often triggered by strong emotions like laughter or surprise.
The main aim of this study is to see how well these new pitolisant tablets are absorbed into the body compared to the version of the drug that is already available. Think of it like comparing different brands of the same vitamin; the goal is to make sure the new versions deliver the same amount of the active ingredient into your system. This is an important step in developing new medicines, as it helps us understand if the new tablets will work properly and safely.
By taking part, healthy volunteers will help scientists understand more about how these new drug forms work in the human body. This crucial early research helps pave the way for potential future treatments for people living with narcolepsy. It's a foundational step to ensure new medications are effective before they are tested in people who actually have the condition.
Key takeaways
- This study is testing new versions of a drug for narcolepsy called pitolisant.
- It aims to see how well these new tablets are absorbed by the body compared to the existing one.
- It's an early-stage study focusing on how the drug works in healthy men.
- Participants will take different tablet forms and have blood samples taken.
- Your involvement helps advance future treatments for narcolepsy.
Who may be eligible?
This study is specifically looking for healthy male volunteers. You'll need to be at least 18 years old, and there isn't an upper age limit mentioned, so older men may also be able to take part if they are otherwise healthy. Being 'healthy' means you shouldn't have any major medical conditions that could affect how the study drug works or how your body handles it.
Because this study is an early-stage test focusing on how the drug behaves in the body, it's designed for people who don't have narcolepsy or other long-term health issues. The researchers want to get a clear picture of the new drug forms without other health problems complicating the results. Specific details about what makes someone 'healthy enough' will be discussed by the study team.
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 a healthy male?
- Are you currently at least 18 years old?
- Do you understand that this study is not for people with narcolepsy?
- Are you able to visit the study clinic multiple times for assessments?
What does participation involve?
As this is a single-dose study, you would come to the study center on different occasions to take one of the four new pitolisant tablet forms, or the existing one. There will be rest periods between each dose, so the effects of one dose can clear from your body before you take the next. During your visits, you would have some standard health checks, and blood samples would be taken regularly after you take each tablet. These blood samples help the researchers measure how much of the drug is in your system and how quickly it's absorbed and removed. The total length of your participation would depend on the number of doses and the wash-out periods required.
Potential risks and benefits
Locations (1)
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Common questions
What is narcolepsy?
Narcolepsy is a long-term brain condition that causes you to suddenly fall asleep at inappropriate times, and can also cause sudden muscle weakness (cataplexy).
What is pitolisant (Wakix®) used for?
Pitolisant is a medicine approved to treat excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.
Why are you testing new tablet forms?
Researchers are looking for ways to improve the existing medication, and testing new tablet forms helps ensure they are absorbed correctly by the body and work effectively.
Will I get paid for taking part?
Information about compensation for your time and travel will be provided by the study team if you are eligible and interested.
Can I decide to leave the study once I've started?
Yes, you are free to leave the study at any point, for any reason. Your medical care will not be affected if you withdraw.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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