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AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A trial in healthy participants to find out how long JNJ-101556143 stays in and acts on the body when administered as different formulations and under different food conditions

This research study is for healthy adult men and is focused on a new medicine called JNJ-101556143. While this medicine might one day help people with prostate cancer, this particular study is just about understanding how the medicine behaves in the body of healthy volunteers. The main goal is to see how long JNJ-101556143 stays in the body and how it works. Scientists also want to compare different forms of the medicine (like if it's a tablet or a liquid) and see if eating food at the same time changes how the medicine is absorbed. This information is really important for developing new medicines safely and effectively.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Janssen Cilag International
Enrolment target
48
Start
09 Jun 2026

What is this study about?

Imagine scientists are trying to build a new car, but first, they need to understand how the engine works on its own, without having to drive it anywhere. This study is a bit like that. Researchers are looking at a new medicine called JNJ-101556143. While this medicine is being developed to potentially help people with prostate cancer in the future, this specific study isn't looking at cancer at all. Instead, it's a very early-stage study focused purely on understanding the medicine itself.

The main aim is to find out what happens to JNJ-101556143 once it enters the body. They want to know two key things: how long it stays in the body before it's gone, and how well it's absorbed and used by the body. They will be testing the medicine in different ways, for example, comparing a pill form to a liquid form, and also checking if taking the medicine with or without food changes how it works. This kind of information is vital because it helps doctors and scientists figure out the best way to give new medicines to people in the future, making sure they are both safe and effective.

Studies like this, called 'Phase I' studies, are a really important first step in bringing new medicines to people. By understanding how the medicine behaves in healthy bodies, researchers can then move on to later studies with patients to see if it actually treats the condition it was designed for. It helps lay the groundwork for future medical progress.

Key takeaways

  • This is an early-stage study for healthy men aged 18 and over.
  • It aims to understand how a new medicine, JNJ-101556143, works in the body.
  • Researchers will test different forms of the medicine and how food affects it.
  • Your direct health will be monitored closely throughout the study.
  • Participation will involve clinic visits and health assessments.
  • The study helps develop future treatments for conditions like prostate cancer.

Who may be eligible?

To be part of this study, you need to be a healthy man, aged 18 or older. Being 'healthy' means that doctors will check to make sure you don't have any major ongoing health problems that could affect how the medicine works or put you at extra risk.

There will be a screening process where doctors and nurses will ask you questions about your health, medical history, and do some basic health checks like blood tests and a physical exam. This is to ensure the study is as safe as possible for everyone involved and that the results are clear.

Typically, people who are taking other medications, have serious allergies, or have a history of certain health conditions would not be able to join. The research team will go through all the specific requirements with you in detail to see if you're a good fit.

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.

  1. Are you a man?
  2. Are you 18 years old or older?
  3. Are you generally in good health?
  4. Are you willing to undergo medical check-ups and give blood/urine samples?
  5. Are you able to commit to several clinic visits, possibly including overnight stays?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first go through a screening visit to make sure you meet all the health requirements. If you qualify, you would then come to a clinic for several visits, which might include staying overnight for some of them. During these visits, you’d receive the study medicine, JNJ-101556143, in different ways (e.g., as a pill or a liquid, sometimes with food, sometimes without).

Throughout the study, you'd undergo various assessments. These typically include blood and urine tests to measure how the medicine is behaving in your body, regular check-ups, and monitoring of your general health and any potential side effects. The total duration of your participation, including all visits and follow-ups, would be explained in full detail by the study team, but these types of studies often involve several weeks or months of commitment.

Potential risks and benefits

Taking part in any medical study carries potential risks. You might experience side effects from the study medicine, which could be mild (like a headache) or, in rare cases, more serious. The research team will carefully monitor you for any problems. You will not directly benefit from this specific study as it is for healthy volunteers, but the information gained will help advance medical science, potentially leading to new treatments for others in the future. Remember, your participation is completely voluntary, and 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.
  • Unverified
    Belgium

Common questions

Why is this study looking at healthy people, not prostate cancer patients?

This early-stage study helps researchers understand how the medicine works in the body without other health conditions making it complicated. It's a key first step before testing it on patients.

Will I get treatment for prostate cancer if I join this study?

No, this study is about understanding the medicine's behaviour in healthy men, not about treating prostate cancer. You will not receive any cancer treatment.

What kind of medicine is JNJ-101556143?

It's a new medicine being developed. The researchers are trying to learn how much of it gets into your body and how long it stays there.

Will I have to stay overnight at a clinic?

It's possible. Some parts of the study, especially when they give you the medicine and take blood samples, might require you to stay at the clinic for a short period.

Do I get paid for taking part?

Typically, participants in healthy volunteer studies receive some compensation for their time and travel. The study team will provide details on this.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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