Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Single-dose, Open-label, Randomized, Crossover Study to Assess the Relative Oral Bioavailability of a JNJ-77242113 Phase 3 Immediate-release Tablet Formulation with Respect to the Phase 2 Immediate-release Tablet Formulation and to Assess the Food Effect of a JNJ-77242113 Phase 3 Immediate-release Tablet Formulation in Healthy Participants

This research is investigating a new medication, JNJ-77242113, which is being developed to treat inflammatory conditions. The study has two main goals. Firstly, it's comparing two different tablet versions of the medicine (Phase 3 versus Phase 2) to see how effectively they release the drug into your body after you swallow them. Secondly, it's looking at whether eating food before taking the Phase 3 tablet changes how your body absorbs the medicine. The study will measure the amount of the drug in the blood over time to understand these effects. This is a very early stage of testing in healthy people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Janssen - Cilag International

Enrolment target

Start

28 Jun 2023

Inflammatory Conditions

What is this study about?

This study is about a new medicine, JNJ-77242113, which is designed to help people with inflammatory conditions. Inflammatory conditions are health problems where parts of the body become swollen, painful, or irritated. Researchers want to make sure this new medicine works as well as possible and is safe.

The main purpose of this study is to understand how your body handles the new medicine once you've taken it. They are comparing two slightly different versions of the JNJ-77242113 tablet currently being developed. One version is an older one (Phase 2), and the other is the newer, more advanced version (Phase 3). By comparing them, scientists can see if the newer tablet delivers the medicine into your bloodstream in the best way. They are also checking to see if eating food before taking the Phase 3 tablet changes how much of the medicine gets absorbed into your body or how quickly it gets there. This information is important for knowing how people should take the medicine in the future.

This type of study is called a 'Phase 1' study. This usually means it's one of the first times the medicine is being given to people, and it’s done in healthy volunteers. The aim here is not to treat an illness, but to gather important information about how the drug behaves in the body before it's tested in people who actually have inflammatory conditions.

Key takeaways

This study is for a new medicine called JNJ-77242113 for inflammatory conditions.
It's an early-stage study in healthy volunteers.
Researchers are comparing two versions of the tablet and checking how food affects absorption.
The goal is to understand how the medicine behaves in the body.
Your participation helps develop future treatments for inflammatory conditions.
You have the right to leave the study at any time.

Who may be eligible?

This study is looking for healthy volunteers. To take part, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate.

Both men and women are welcome to join this study. The researchers aim to include a wide range of people to understand how the medicine works in different bodies.

Since this is an early-stage study in healthy people, there will be other specific health requirements for who can and cannot take part. For example, you likely couldn't join if you have certain existing health conditions or take particular medicines. These details would be explained fully by the study team.

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 a generally healthy person?
Are you able to visit the study clinic multiple times?
Are you comfortable with having blood samples taken regularly?

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, JNJ-77242113. Because it's a 'crossover' study, you would receive each different version of the tablet (Phase 2 and Phase 3) and experience the food effect conditions, but at different times with a 'washout' period in between.

During your participation, the study team would take regular blood samples after you've taken the medicine. These samples help them measure how much of the drug is in your body and how it changes over time. You would also have physical check-ups and other tests to make sure you remain healthy throughout the study.

The total duration of your involvement in the study would depend on the number of dosing periods and follow-up required. You would need to attend the study clinic for several visits, which may include overnight stays, and have follow-up calls or visits after each dosing period. All procedures and the full time commitment would be explained in detail before you agree to participate.

Potential risks and benefits

Participating in a study like this might not directly benefit your health, as it's an early-stage study in healthy volunteers. However, your involvement is crucial for helping to develop new medicines that could benefit many people with inflammatory conditions in the future. Potential risks could include side effects from the medicine, discomfort from blood draws, or allergic reactions. All known and potential risks will be thoroughly explained to you, and you will be carefully monitored throughout the study. You have the right to withdraw from the study at any time, for any reason, without affecting your standard 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 are inflammatory conditions?

These are health problems where parts of your body become swollen, painful, or irritated. Examples include conditions like arthritis or bowel diseases.

Why are they studying healthy people?

Early studies often use healthy volunteers to understand how a new medicine behaves in the body without other health issues making it complicated. This helps ensure it's safe before testing in patients.

What does 'bioavailability' mean?

It's about how much of the medicine actually gets into your bloodstream and is available to work in your body.

What is a 'crossover study'?

It means you will receive all the different study treatments (like the different tablet versions or with/without food) at different times, with a break in between. This helps compare them in the same person.

Will I know if I'm getting the old or new tablet?

No, this is an 'open-label' study, which means both you and the study team will know which version of the tablet you are receiving at a given time.