Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An Open-label, Single-dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Aticaprant (JNJ-67953964)

This early-stage study, called a Phase I trial, is looking at a new medicine named Aticaprant. Researchers want to understand how your body handles this medicine, especially how it gets rid of it. They are specifically interested in how healthy kidneys might affect this process. By studying this, they can make sure the medicine is safe and effective when it's eventually given to people who need it. This trial involves healthy adult volunteers and helps scientists learn vital information before giving the medicine to patients with specific health conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Janssen - Cilag International

Enrolment target

Start

10 Nov 2023

Healthy Adult Participants

What is this study about?

Imagine your body as a complex machine that takes in food and medicine, uses what it needs, and then gets rid of what's left. When you take a new medicine, scientists need to understand exactly how your body processes it – how much gets absorbed, how it travels around, and how it eventually leaves your body. This process is often called 'pharmacokinetics'.

This particular study is focusing on a new medicine called Aticaprant. It's an 'open-label' study, which means everyone involved (both the participants and the research team) knows what medicine is being given. This is common in very early-stage studies when the main goal is to understand how the body handles the medicine.

The main aim here is to see if having healthy kidneys changes how your body deals with Aticaprant. Kidneys are super important in filtering waste and medicines from your blood. By understanding how Aticaprant behaves in people with healthy kidneys, researchers can predict how it might act in people with kidney problems later on. This information is crucial for figuring out the right dose for different people in the future.

Key takeaways

This is an early-stage study (Phase I) for a new medicine called Aticaprant.
It aims to understand how healthy bodies process and get rid of the medicine.
Only healthy adults aged 18 or over can participate.
All participants receive the active medicine; there's no placebo.
Participation involves taking a single dose and having your health monitored.
The study helps scientists find the right doses for future patients.

Who may be eligible?

This study is looking for healthy adult volunteers. That means you shouldn't have any major ongoing health problems, and your body should be working as it normally would.

You need to be at least 18 years old to take part. There isn't an upper age limit mentioned, so older adults who are generally healthy might also be able to join.

Both men and women are welcome to participate in this research. The most important thing is that you are considered healthy by the study doctors.

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?
Do you not have any major ongoing medical conditions?
Are you able to attend several appointments at a clinic?
Are you willing to discuss your health history openly with the study team?
Are you comfortable with having blood samples taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of the study medicine, Aticaprant. The research team would then closely monitor you over a certain period. This would involve a number of visits to the study clinic, where you would have blood samples taken to see how the medicine is moving through your body and how quickly it's being removed. You might also have other check-ups, like blood pressure readings and general health assessments, to make sure you're doing well. The full duration of your involvement, including all visits and follow-ups, would be explained to you before you agree to participate.

Potential risks and benefits

Taking part in any study always involves a balance of potential benefits and risks. A potential benefit of this study is contributing to medical science and helping to develop new treatments that could help many people in the future. You will also receive careful medical monitoring during your participation. Potential risks could include side effects from the study medicine, which would be explained in detail. There's also the chance of discomfort from procedures like blood draws. You will be given a full explanation of all known risks before you make any decision, and you always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

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's given to patients. It's not yet available as a treatment.

Why are you only studying healthy adults?

In early studies like this, researchers often start with healthy volunteers. This helps them understand how the medicine behaves in a 'normal' body without other health conditions making things complicated.

What is 'pharmacokinetics'?

Pharmacokinetics is a scientific term that describes how your body handles a medicine – how much is absorbed, where it goes, and how quickly it leaves your system.

Will I get paid for taking part?

Some studies offer payment for your time and travel, but this information isn't always listed here. You should ask the study team directly about any reimbursement available.

What does 'Open-label' mean?

Open-label means that everyone involved – you, the doctors, and the nurses – will know which medicine you are receiving. There are no 'placebos' or 'dummy' treatments in this particular study.