An Open-Label, Single-Center, Single-Dose Study to Assess the Absolute Oral Bioavailability and Pharmacokinetics of Aticaprant Administered as an Oral Tablet and an Intravenous Infusion Microdose of 14C-Aticaprant in Healthy Participants
This research study is for healthy adults and is focused on a new medicine called Aticaprant (also known as JNJ-67953964). The main goal is to understand how much of the drug gets into your body and how quickly, both when you take it as a tablet and when a tiny amount is given through a drip into your arm. This is called 'absolute bioavailability' and 'pharmacokinetics'. By comparing these two ways of giving the drug, scientists can learn more about how the body handles this new medicine. This is a very early stage study, designed to gather basic information about the drug's journey through the body in a safe way.
At a glance
What is this study about?
Imagine you take a new medicine. How much of it actually gets into your bloodstream to do its job? And how fast does it get there? That's exactly what this study aims to find out for a new drug called Aticaprant.
Researchers want to compare two ways of giving this medicine: as a regular tablet you swallow, and as a very small, special dose given directly into your vein using a drip. By doing this comparison, they can figure out how effectively the tablet delivers the drug to your body compared to putting it straight into your blood. This is important because it helps them understand the best way to make the medicine work. Think of it like comparing how much water gets to a plant if you pour it into a pot versus directly into its roots.
This kind of study is called a 'Phase 1' study, which means it's one of the very first times this drug is being tested in people. It’s not about treating a disease yet, but purely about understanding the drug itself – how your body takes it in, processes it, and gets rid of it. This essential information helps drug developers decide if the medicine is worth developing further and how to give it to patients in the future.
Key takeaways
- This study helps understand how a new drug called Aticaprant is absorbed by the body.
- It compares taking the drug as a tablet versus a tiny amount given through a drip.
- Only healthy adults aged 18 and over can join.
- This is an early-stage study (Phase 1) focused on drug safety and how it moves through the body.
- Participation involves visits to a clinic, taking the drug, and blood tests.
Who may be eligible?
This study is specifically looking for healthy adults. You must be at least 18 years old to take part. There is no upper age limit mentioned, so older adults can also be considered.
The study is open to both men and women. The most important thing is that you are generally healthy and don't have any major medical conditions, as the study aims to understand how the drug behaves in a healthy person's body without other health issues interfering.
Further checks will be done by the study team to make sure you are a good fit and that participating would be safe for you. This might include a medical exam and blood tests.
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?
- Do you consider yourself generally healthy?
- Are you able to attend appointments at a specific study centre?
- Are you comfortable with taking new medication and having blood tests?
What does participation involve?
If you decide to take part, you'll be given the study drug in two different ways at different times: first, you'll take it as a tablet, and for the second part, you'll receive a very tiny, special dose through a drip into your arm. This will happen at a single study centre. You'll have several visits to the study centre, which will involve giving blood samples regularly to see how the drug levels change in your body over time. There will also be health checks and simple tests to ensure you're doing well. The total time you'll be involved in the study, from your first visit to your last follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is Aticaprant?
Aticaprant is the name of a new medicine that is being studied. It's also known by its research name, JNJ-67953964.
What does 'healthy participants' mean?
It means the study is looking for people who generally feel well and don't have any serious ongoing medical conditions, so researchers can focus on the drug's effects without other health issues getting in the way.
What is a 'microdose'?
A microdose is an extremely small amount of the drug, much smaller than a regular dose. It's used to safely track how the drug moves through the body without causing much effect.
Why do they give it as a tablet and by drip?
By comparing how the drug works when swallowed as a tablet and when given directly into the bloodstream (drip), researchers can understand how much of the tablet dose actually gets into the body.
Will this study cure any illness?
No, this is an early-stage study just to understand the drug's basic properties in healthy people, not to treat any specific illness.
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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