Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A two-part trial in healthy volunteers to find out how long JNJ-77242113 stays in and acts on the body when administered as different tablet formulations and under different food and water conditions, and to assess the acceptability profile (taste, palatability, and smell) of JNJ-77242113 formulations.

This study is looking at a new medicine called JNJ-77242113. This medicine is being developed to treat conditions that cause swelling and irritation in the body, like some skin problems or joint issues. In this first phase of testing, we are asking healthy volunteers to take the medicine. We want to understand how the body handles the medicine, how long it stays in the system, and how well it works when taken in different ways, such as in different tablet forms or with different amounts of food or water. We're also checking how the medicine tastes and smells to make sure it's acceptable for people to take. This information is important for making sure the medicine can be given safely and effectively in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Janssen Cilag International

Enrolment target

Start

03 May 2024

Inflammatory Conditions

What is this study about?

This study is a very early step in testing a new medicine called JNJ-77242113, which is being developed to help people with conditions that cause inflammation. Inflammation is when a part of your body becomes swollen, red, hot, or painful, and it's a common problem in many illnesses, such as certain skin or joint conditions.

Because this is a new medicine, we first need to understand how it behaves in the human body. We're asking healthy volunteers to take JNJ-77242113 in different ways, such as different types of tablets and with or without food and varying amounts of water. This helps us learn about things like how quickly the body absorbs the medicine, how long it stays in the body, and how the body gets rid of it. We also want to know if the taste or smell of the medicine is acceptable, which is important for people to be able to take it comfortably.

This type of study, called a Phase I or 'Human Pharmacology' study, is crucial. It helps us gather important safety information and figure out the best way to give the medicine before it's tested in people who actually have the inflammatory conditions. The goal is to develop a new and effective treatment that is easy for patients to take.

Key takeaways

It's a study for a new medicine, JNJ-77242113, for inflammatory conditions.
Healthy adults (18+) are needed to participate.
The study tests how the medicine works in the body and how it tastes.
It's an early-stage study to gather important safety information.
Your contribution helps discover new treatments for future patients.

Who may be eligible?

This study is looking for healthy volunteers who are at least 18 years old. Both men and women can take part.

To be considered for this study, you must generally be in good health. This means you shouldn't have any serious ongoing medical conditions that could affect how your body handles the study medicine or create a risk for you. You would also need to meet other specific health criteria during a screening check-up.

If you have certain health issues or are taking particular medications, you might not be able to join. The study team will review your full medical history to make sure it's safe for you to participate.

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 several study visits?
Are you a man or a woman?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, JNJ-77242113, in different ways – meaning you might take different forms of tablets or take them under different conditions, like with food or after not eating for a while. You would have a number of visits to the study clinic or hospital where doctors and nurses would perform various checks. These checks might include blood tests, urine tests, measuring your vital signs (like blood pressure and heart rate), and asking you questions about how you’re feeling and any side effects. The total duration of your participation would involve these visits and follow-up checks, ensuring we gather all necessary information safely. The study is divided into two main parts.

Potential risks and benefits

As with any clinical trial, there are potential benefits and risks. You might not directly benefit from taking part in this early-stage study, as the main goal is to gather information about the new medicine. However, your participation will help advance medical knowledge, potentially leading to new treatments for inflammatory conditions in the future. Potential risks might include side effects from the medicine, the discomfort of blood tests, or other procedures. 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 JNJ-77242113?

It's a new medicine being tested to treat conditions that cause swelling and irritation in the body.

Who can join this study?

Healthy men and women who are 18 years and older can take part.

Why are different tablet forms being tested?

Researchers want to find the best way for the body to take in and use the medicine most effectively.

Will I experience side effects?

Possibly. All medicines can have side effects, and the study team will monitor you closely for any changes.

Will I be paid for participating?

This information is usually discussed in detail during the consent process and can vary by study site.