Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to assess the effect of single and repeated doses of JNJ-81241459 on a single dose of certain other drugs, when given together to healthy adult participants

This study is designed for healthy adult volunteers and explores how a new medicine, JNJ-81241459, behaves in the body when it's taken alongside other medicines. Researchers want to see if JNJ-81241459 changes how these other drugs work, or if they change how JNJ-81241459 works. This is a very early-stage study, often called a 'Phase I' study, which means it's one of the first times this new medicine is being tested in people. Understanding these interactions is crucial, especially for future patients who might take JNJ-81241459 for conditions like plaque psoriasis, ensuring treatments are safe and effective when used with other medications.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Janssen Cilag International

Enrolment target

Start

05 Mar 2024

Plaque Psoriasis

What is this study about?

Imagine you take a new medicine for a skin condition, but you also take another medicine for a headache. This study is like a careful test to see what happens when these two types of medicines are taken at the same time. The new medicine being studied is called JNJ-81241459. Researchers want to find out if taking JNJ-81241459 changes how other medicines work in your body, or if those other medicines change how JNJ-81241459 works.

This kind of study is called a 'Human Pharmacology' study, or 'Phase I'. It's usually one of the very first steps in testing a new medicine in people. These studies are designed to be very safe and are done with healthy adult volunteers. The main goal isn't to treat an illness, but to understand what the medicine does in the body, how much of it stays in the blood, and how it interacts with other common drugs.

Why does this matter? For people who eventually might take JNJ-81241459 for conditions like plaque psoriasis (a skin condition causing red, scaly patches), it's really important for doctors to know if they can safely take it with other medicines they might be on. This study helps doctors understand how to give JNJ-81241459 safely and effectively in the future, making sure patients get the best care.

Key takeaways

This study helps understand how a new medicine interacts with other drugs.
It's for healthy adults aged 18 and over, both men and women.
The new medicine, JNJ-81241459, is being developed for conditions like plaque psoriasis.
This is an early-stage study, focused on safety and how the medicine works in the body.
Participation involves taking medicines and regular health check-ups.
You can withdraw from the study at any time.

Who may be eligible?

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

Both men and women are welcome to participate in this research. The study needs a variety of people to get a good understanding of how the medicine works.

Because this is a study about how medicines interact, you will need to be in good general health. The study team will do checks to make sure you are healthy enough to take part and that it's safe for you.

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 Male or Female?
Are you able to commit to several clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive single and repeated doses of the new medicine (JNJ-81241459) alongside a single dose of certain other common medications. This would likely involve several visits to a clinic over a period of time. During these visits, the study team would monitor your health closely. This would probably include things like blood tests, checking your blood pressure and heart rate, and asking you how you feel. The exact number of visits, how long each visit lasts, and the total duration of your involvement in the study would be explained to you fully before you agree to take part. It's important to know that you would receive the study medicines and have regular check-ups to make sure everything is going well.

Potential risks and benefits

While there isn't a direct health benefit for you, taking part in a study like this helps advance medical science and could indirectly benefit future patients with conditions like plaque psoriasis. There are potential risks, as with any medicine, which might include side effects from JNJ-81241459 or the other medicines given. The study team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future 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-81241459?

It's a new medicine being tested. This study is an early step to understand how it works in the body.

What does 'Plaque Psoriasis' have to do with the study?

While you don't need to have psoriasis to join, JNJ-81241459 is being developed for conditions like plaque psoriasis. This study helps ensure it can be safely used by future patients with that condition.

Will I get paid for taking part?

Often, early-phase studies for healthy volunteers offer payment for time and travel. Ask the study team about this.

What does 'Phase I' mean?

Phase I is the first time a new medicine is tested in people. It mainly checks safety and how the medicine acts in the body.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.