Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An Open-label, Single-dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-77242113 in Adult Participants

This study is investigating a new medicine called JNJ-77242113. We are looking at how this medicine acts in the body, specifically in adults who have kidney problems. When someone has kidney impairment, their kidneys might not work as well as they should, which can affect how medicines are processed and removed from the body. We want to understand if kidney function changes how JNJ-77242113 is handled by the body. To do this, participants will receive a single dose of the medicine, and then doctors will take blood samples to measure how much of the medicine is in the body over time. This helps us learn more about the medicine's effects in people with different levels of kidney health.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Janssen Cilag International

Enrolment target

Start

13 May 2024

Renal Impairment

What is this study about?

This study is focused on understanding how a new medicine, called JNJ-77242113, works inside the body of people who have kidney problems. Our kidneys play a really important role in filtering our blood and getting rid of waste products, including medicines, after they've done their job. If someone's kidneys aren't working as well as they should, it can change how a medicine behaves – perhaps it stays in the body longer, or is cleared out more quickly. This information is crucial for doctors to know the right dose to give patients, especially those with kidney conditions.

The main goal of this particular study is to see how kidney health affects the journey of JNJ-77242113 through the body. This is called 'pharmacokinetics.' It basically means we're tracking the medicine's path: how it's absorbed, distributed, broken down, and eventually removed from the body. By giving participants a single dose and then carefully monitoring its levels in their blood over time, we can gather vital information.

Because this is an early-stage study (sometimes called Phase 1), it's all about understanding the medicine's basic behaviour, rather than testing if it treats a specific illness. The results from this study will help ensure that if JNJ-77242113 goes on to be used more widely, doctors will know how to safely and effectively prescribe it to people with varying degrees of kidney function. This ultimately helps make future treatments safer and more suitable for everyone.

Key takeaways

This study explores how a new medicine works in people with kidney issues.
It's an early-stage study, focusing on understanding the medicine's behaviour, not treatment.
Participants receive a single dose, followed by blood tests to track the medicine.
The information helps guide future safe use of the medicine.
Both men and women aged 18 and older can be considered.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years and older. Both men and women are welcome to take part. The main focus is on individuals who have kidney problems, as this is what the study is investigating. Healthy volunteers might also be included for comparison.

Before joining, doctors will carefully check your health to make sure the study is safe for you. They will review your medical history and conduct tests to confirm your kidney function falls within the study's requirements. This ensures the results are clear and that all participants are looked after.

Exact reasons why someone might not be able to join will be explained by the study doctor. These could include other health conditions or certain medications you're currently taking. It's important to discuss your full medical history openly with 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?
Do you have kidney problems, or are your kidneys perfectly healthy?
Are you able to visit a study clinic for assessments?
Are you willing to have blood samples taken regularly after receiving a single dose of medicine?
Are you comfortable potentially staying at the clinic overnight or for a few days?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of the study medicine, JNJ-77242113. This medicine would be given to you at the study clinic. After receiving the dose, you would need to stay at the clinic for a period of time, possibly overnight or for a few days. During this time, the study team would take regular blood samples to measure how the medicine is moving through your body. There will also be other health checks, like measuring your blood pressure and heart rate. You might have follow-up visits, but the main part of the study involves the initial stay and blood tests after the single dose. The total duration of your involvement could range from a few days to a couple of weeks, depending on the schedule of blood tests and follow-up checks.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might not directly benefit from taking part in this early-stage study, as it's mainly for gathering information about the medicine. However, you would be helping researchers learn more about how medicines work, which could help future patients. Potential risks could include side effects from the study medicine, discomfort from blood tests, or other reactions. The study team will explain all known risks in detail. Remember, your participation is completely voluntary; you can choose to withdraw from the study at any time, for any reason, without it affecting your usual 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
Germany

Common questions

What is JNJ-77242113?

It's a new medicine being studied. This particular study is not testing it for a specific illness, but rather understanding how it behaves in the body.

Why is this study looking at kidney problems?

Kidneys help clear medicines from the body. If your kidneys aren't working well, it can change how a medicine acts, so we need to understand this for JNJ-77242113.

Will I get better if I join this study?

This study is mainly for research and gathering information. It's not designed to treat an illness, so any personal health benefits are not guaranteed.

How long will I have to stay at the clinic?

After receiving the single dose, you might need to stay at the clinic for a certain period, possibly overnight or for a few days, so doctors can take regular blood samples.

Can I leave the study if I change my mind?

Yes, your participation is voluntary. You can decide to leave the study at any time, for any reason, without penalty or affecting your medical care.