A study in healthy volunteers to find out how long aticaprant stays in and acts on the body when administered with or without food and with or without fluconazole
This study is for healthy adult volunteers to help us learn more about a new medicine called aticaprant. We want to understand how it behaves in the body. Specifically, we'll be looking at how long it takes for the medicine to be absorbed, how long it stays active, and how the body gets rid of it. We also want to see if taking aticaprant with food makes a difference, and if another common medicine called fluconazole affects how aticaprant works. This is an early-stage study, which means it's one of the first times this medicine is being tested in people. The information we gather will help us develop this medicine for future use.
At a glance
What is this study about?
This study is about a new medicine called aticaprant. We're asking healthy volunteers to join because we need to understand how this medicine works inside the human body. Think of it like learning how a new car engine runs — we need to see how efficiently it uses fuel, how long it can run, and if certain conditions (like adding special fuel or driving uphill) change how it performs.
Specifically, researchers want to see how long it takes for aticaprant to get into your system, how long it stays active there, and how your body eventually gets rid of it. This is really important information because it helps doctors figure out the right dose to give patients and how often they should take the medicine. They also want to see if eating food at the same time as taking aticaprant changes how your body handles the medicine. This is common with many medicines, where food can speed up, slow down, or even stop the medicine from working as well.
Finally, the study will also look at whether a common anti-fungal medicine called fluconazole, which many people take for infections, affects how aticaprant behaves in the body. Sometimes, taking two medicines at once can change how each one works. By understanding these things early on, researchers can make sure that when aticaprant is eventually given to patients who need it, it will be as safe and effective as possible.
Key takeaways
- Study examines how a new medicine, aticaprant, works in the body.
- Specifically looks at how long it stays and acts, and if food or fluconazole affects it.
- Open to healthy adult volunteers, aged 18 and over.
- Involves clinic visits, medication, blood tests, and health checks.
- This is an early-stage study to gather important safety and drug behaviour information.
Who may be eligible?
This study is looking for healthy adults. This means you should generally be in good health and not have any serious ongoing medical conditions. The study is open to both men and women.
You need to be at least 18 years old to take part. There is no upper age limit, meaning older adults who are otherwise healthy can also participate.
The research team will review your medical history and do some health checks to make sure the study is a good fit for you and that taking part would be safe.
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 generally healthy?
- Are you 18 years old or older?
- Are you willing to attend regular clinic visits?
- Are you comfortable with blood and urine tests?
- Are you able to follow specific instructions for taking medication?
What does participation involve?
If you decide to take part, you'll be given the medicine called aticaprant. You might take it with or without food, and some participants might also take fluconazole at the same time. The study will involve several visits to a clinic over a set period. During these visits, the research team will monitor your health closely. This will likely involve regular blood and urine tests to see how the medicine is moving through your body, and checks of your vital signs, like your blood pressure and heart rate.
The total amount of time you spend in the study will depend on the specific schedule, but it will involve a period of taking the medication and then follow-up visits. The research team will explain the full schedule, including how many visits there are and how long each visit might be, before you agree to join.
Potential risks and benefits
Locations (1)
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Common questions
What is aticaprant?
Aticaprant is a new medicine that is being studied. This research aims to understand how it works in the body before it can be used for treating specific conditions.
Why is this study only for healthy people?
Early-stage studies often start with healthy volunteers to see how a new medicine works in a typical, healthy body without other health problems complicating the results.
Will I know if I'm taking the medicine with food or another medicine?
The research team will clearly explain all parts of the study, including when and how you should take the medicine, and if another medicine like fluconazole is involved for your group.
What is a 'Phase I' study?
Phase I means it's one of the first times the medicine is being tested in humans. The main goal is to check how safe it is and how it behaves in the body, rather than treating a disease.
Will I get paid for taking part?
Payment for participation varies between studies and will be explained fully by the research team if applicable. You should ask about this directly.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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