Open label, single-center, four-part registration pharmacokinetic study: Part I: Pilot 2-way cross-over randomized, comparative pharmacokinetic study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation versus the reference formulation, after a single 20 mg oral administration in twelve healthy subjects, in order to evaluate the adequate sample size to demonstrate the bioequivalence. Part II: One sequence cross-over, drug-drug interaction pharmacokinetic study between a proton pump inhibitor (PPI) (pantoprazole 40 mg) and a new gastro-resistant 20 mg pitolisant hydrochloride formulation in eighteen healthy subjects. Part III: Pivotal 4-way replicate design cross-over randomized, bioequivalence study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation versus the reference formulation, after single oral 20 mg administration in healthy subjects. Part IV: 2-way cross-over randomized, food effect study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation administered under fasting conditions and after a standard FDA High Fat Breakfast in eighteen healthy subjects.
This research is testing a new version of a medication called pitolisant, which is used to treat conditions like narcolepsy (a sleep disorder). The study has four main parts, all involving healthy volunteers. Researchers want to see if the new medicine gets into the body in the same way as the current one. They'll also check if it reacts with a common stomach medicine (a 'proton pump inhibitor') and if eating a meal changes how the body absorbs it. This helps make sure the new medicine works well and is safe for patients.
At a glance
What is this study about?
This study is focused on a new way to deliver a medicine called pitolisant hydrochloride, which helps people with narcolepsy, a condition that causes excessive daytime sleepiness. The researchers want to make sure this new version of the medicine works just as well and is safe when compared to what's already available. They're doing this by trying it out on healthy volunteers.
The study is broken down into four main parts. First, they'll compare the new medicine to the old one in a small group to figure out the best way to do larger tests. Then, they'll see if the new medicine interacts with a common stomach-acid reducing drug, which is important because many people take these medicines. They'll also do a bigger comparison between the new and old medicine.
Finally, they'll investigate if eating food, especially a high-fat meal, changes how the new medicine is absorbed by the body. This information is really important because it helps doctors know whether patients should take the medicine with food or on an empty stomach to get the best effect. All these steps help researchers understand the new medicine better before it can be used more widely.
Key takeaways
- This study is testing a new way of giving a narcolepsy medicine called pitolisant.
- It involves healthy adult volunteers, not people with narcolepsy.
- Researchers want to see if the new medicine is absorbed by the body in the same way as the old one.
- They will also check if the medicine interacts with a common stomach medicine or if food affects it.
- The study has four distinct parts, focusing on different aspects of the new medicine.
Who may be eligible?
This study is looking for healthy adults aged 18 and over. Both men and women can take part.
Because this study is testing how a new medicine moves through the body, they need people who are generally well. This helps them understand the medicine's effects without other health issues getting in the way. Specific criteria not listed here might exclude people with certain health conditions or those taking particular medicines, so it's always important to discuss your full health history.
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 healthy?
- Are you able to visit a single clinic for study appointments?
- Are you comfortable with having blood samples taken?
- Are you not taking any medications that might interfere with the study ones (this would be checked by the study team)?
What does participation involve?
Taking part in this study would involve spending time at a single hospital clinic. You would receive single doses of the study medication or the existing version. You will have blood samples taken at various times to see how the medicine is absorbed and leaves your body. For some parts, you might take the medicine with or without food, or with another common stomach medication. The study involves different visits over a set period, but the total duration isn't specified here.
Potential risks and benefits
Locations (1)
- —UnverifiedBelgium
Common questions
What is narcolepsy and pitolisant?
Narcolepsy is a condition that makes people very sleepy during the day. Pitolisant is a medicine used to help people with narcolepsy stay awake.
Who can join this study?
This study is recruiting healthy adults aged 18 or older, both men and women.
Will I get the actual medicine for narcolepsy?
You will receive doses of pitolisant in its new or existing form, but you are a healthy volunteer, so it's not a treatment for an illness you have.
What does 'gastro-resistant' mean?
It means the medicine is designed to pass through your stomach without dissolving, so it can be absorbed later in your gut. This can reduce stomach upset or help the medicine work better.
Why do they need healthy people for this study?
Using healthy volunteers helps researchers understand how the medicine works in the body without other health problems affecting the results. This is a common first step for new medicines.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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