Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy volunteers to find out how long aticaprant stays in and acts on the body when administered with or without rabeprazole.

This study is for healthy volunteers and aims to understand a new medicine called aticaprant. Researchers want to find out how long aticaprant stays in the body and what effects it has. They will test it in people who take aticaprant on its own, and also in people who take it alongside another medicine called rabeprazole. This is an early-stage study, meaning it's one of the first times this medicine is being given to people. The main goal is to learn how the body handles aticaprant in different situations, which helps scientists understand if it could be a useful treatment in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Janssen Cilag International

Enrolment target

Start

06 May 2024

Healthy Adult Participants.

What is this study about?

This research study is about a new medicine called aticaprant. It's an early-stage trial, which means it's one of the first times this medicine is being given to people. The main aim is simply to learn how the medicine acts inside a healthy body. Researchers want to understand how long it stays in your system and what happens to it after you take it.

They are also interested in whether another medicine, called rabeprazole, changes how aticaprant works. Rabeprazole is a medicine often used to reduce stomach acid. By giving some participants aticaprant alone and others aticaprant with rabeprazole, the researchers can see if there are any differences in how the body handles aticaprant.

This kind of study is really important because it helps scientists understand the basic way a new medicine behaves. It's a key first step before they can test if the medicine is effective for specific illnesses. By studying healthy volunteers, researchers can get a clear picture of the medicine's properties without other health conditions getting in the way.

Key takeaways

This study is about a new medicine called aticaprant.
It aims to understand how aticaprant works and stays in the body.
Researchers will also see if another medicine, rabeprazole, affects aticaprant.
It's an early-stage study for healthy adult volunteers.
Taking part helps advance medical knowledge.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adult volunteers. This means you should generally be in good health and not have any serious ongoing medical conditions.

You must be at least 18 years old to take part. There is no upper age limit, so older adults are welcome to participate if they meet the other health criteria.

Both men and women can join this study. The researchers want to include a diverse group of people to get a broad understanding of how the medicine works.

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 at least 18 years old?
Do you consider yourself generally healthy?
Do you not have any major ongoing medical conditions?
Are you able to commit to the study requirements (visits, tests)?
Are you comfortable potentially taking two different medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given doses of the study medicine, aticaprant, either on its own or together with rabeprazole. This study does not explain how many visits you would need or how long each visit would last, but typically early-stage studies involve regular visits to a clinic over a period of time. During these visits, you would likely have blood samples taken, and your general health would be checked to see how your body is reacting to the medicine. The total duration of your participation, including any follow-up, is not specified here but would be fully explained before you agree to join.

Potential risks and benefits

Taking part in any medical study carries potential risks. As this is an early-stage study of a new medicine, there might be side effects that are not yet fully known. These side effects could range from mild, like a headache, to more serious, though serious side effects are rare in healthy volunteer studies. You would be closely monitored by medical staff throughout the study. The main benefit is helping advance medical science and potentially contributing to new treatments for future patients. You 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
Belgium

Common questions

What is aticaprant and why are you studying it?

Aticaprant is a new medicine we are investigating. We are studying it to learn how it acts in the body, which is a necessary first step in developing new treatments.

What is rabeprazole and why is it included?

Rabeprazole is a medicine used to reduce stomach acid. We are giving it to some participants alongside aticaprant to see if it changes how aticaprant works in the body.

Will I get paid to be in this study?

The information provided does not say if participants will be compensated. This is a good question to ask the study team if you are interested.

How will I know if I'm taking aticaprant or aticaprant with rabeprazole?

The study design will explain how participants are grouped. You would be fully informed about which medicines you are taking before you agree to join.

Will this study help me with any health problems I have?

This study is for healthy volunteers and is designed to understand how the medicine works, not to treat any existing health problems. We encourage you to speak to your own doctor about any health concerns.