Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Aticaprant (JNJ-67953964)

This research study is trying to understand how a new medication, called Aticaprant (also known as JNJ-67953964), works in the body. Specifically, the researchers want to find out if having liver problems affects how the body processes this medicine. They will give a single dose of the medicine to healthy adults and then carefully track how much of it is in their system over time. They will also be checking to make sure the medicine is safe and doesn't cause too many side effects. This is one of the early steps in testing a new medicine, focusing on its basic effects in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Janssen - Cilag International

Enrolment target

Start

30 Jun 2023

Healthy Adult Participants

What is this study about?

This study is designed to help us learn more about a new medicine called Aticaprant. When a new medicine is developed, scientists need to understand exactly how it works once it's in the human body. This includes how the body takes it in, how it breaks it down, and how it gets rid of it. These processes are often affected by organs like the liver, which plays a big role in processing many medicines.

In this particular study, researchers want to see if the liver's ability to process medicines affects how Aticaprant works. They will give a single dose of the medicine and then monitor its levels in the body. This information is really important because it helps doctors understand how to prescribe the medicine safely and effectively for different people, especially those who might have liver conditions.

By carefully studying how Aticaprant behaves in healthy adults, researchers can gather essential information about its safety and how it is processed. This early-stage research is crucial for making sure that any new medicine, if it goes on to be approved, can be used safely and at the correct dose for everyone who might need it in the future.

Key takeaways

This study is testing a new medicine called Aticaprant.
It aims to understand how the body processes this medicine.
Healthy adults (18 years or older) are needed to participate.
Participants will receive a single dose of the medicine.
Researchers will monitor safety and medicine levels in the body.
This is an early stage of medicine development.

Who may be eligible?

To join this study, people must be healthy adults. This means you should generally be in good health with no serious medical conditions to take part. The study is open to both men and women.

You need to be at least 18 years old to be considered for this study. There isn't an upper age limit mentioned, so older adults who are otherwise healthy may also be able to participate. Your overall health will be checked by the study doctors to make sure it's safe for you to take part.

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 in good health?
Are you able to attend clinic visits?
Are you comfortable with blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a single dose of the study medicine, Aticaprant. After taking the medicine, you would have several visits to the clinic over a period of time. During these visits, the study team would take blood samples to measure how the medicine is processed by your body. They would also monitor your health closely to check for any side effects and ensure your safety. The exact number of visits and the total length of time you'd be involved would be explained in detail before you agree to join.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is contributing to medical knowledge by helping researchers understand how a new medicine works, which could help future patients. Potential risks include experiencing side effects from the study medicine, or discomfort from procedures like blood tests. You will be fully informed of all known risks before you decide to participate, and you are free to withdraw from the study at any time, for any reason, without affecting your regular 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 the name of a new medicine being tested in this study. Researchers are trying to understand how it works in the body.

Why is this study only for healthy adults?

Early studies often start with healthy adults to understand the basic effects and safety of a new medicine without other health conditions making things more complicated.

What does 'single-dose' mean?

It means you would only receive one dose of the study medicine, not repeated doses over time.

Will I know if I'm getting the actual medicine or a dummy pill?

In this specific study, everyone receives the active medicine (Aticaprant), as it's designed to see how the medicine acts in the body.

What does 'hepatic impairment' mean?

'Hepatic impairment' refers to problems with the liver. This study is looking at how the medicine works in people with and without liver issues, though this particular study focuses mainly on healthy adults to get baseline information.