Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in healthy men to learn about how the body absorbs, processes, and removes radioactively labeled BAY 3283142

This study aims to understand how a new medicine, called BAY 3283142, works in the human body. Researchers will give a small, specially marked dose of this drug to healthy men. They will then carefully watch how the body absorbs (takes in), processes (breaks down), and removes (gets rid of) the drug. This information is really important because it helps scientists learn about the drug's effects and how it might work to treat chronic kidney disease. This is a very early stage of testing, often called a Phase I study, where the main goal is to understand how the drug behaves in people, rather than testing its full effectiveness as a treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer AG

Enrolment target

Start

25 Jul 2024

Chronic kidney disease

What is this study about?

Imagine you take a new medicine – how does your body use it? Where does it go after you swallow it? How long does it stay in your system? This study, called 'A study in healthy men to learn about how the body absorbs, processes, and removes radioactively labeled BAY 3283142', aims to answer these very questions for a new potential drug called BAY 3283142. Researchers are giving a tiny, safe amount of this drug, which has a special 'label' that allows them to track it, to healthy men.

The main purpose of this study is to carefully observe how the body takes in (absorbs) the drug, how it changes it (processes it), and eventually how it gets rid of it (removes it). Scientists need this information to understand how BAY 3283142 behaves in people. This helps them work out the best way to use the drug in the future, for example, what dose might be most effective.

This kind of research is a very early step in developing new medicines. It's often called a Phase I study. They're not testing if the drug works to treat a disease yet, but rather how safe it is and how it acts inside the body. The knowledge gained from studies like this is crucial for the safe and effective development of future treatments for conditions like chronic kidney disease.

Key takeaways

This study is exploring how a new drug, BAY 3283142, acts in the body.
It's for healthy men, aged 18 or over, to understand how the drug is absorbed and removed.
The drug will have a small, safe tracker (radioactive label) to follow its journey.
This is a very early stage of research, not testing treatment effectiveness yet.
Results will help inform future development of treatments for chronic kidney disease.

Who may be eligible?

This study is specifically looking for healthy men to take part. This means that if you're a man and generally feel well, without any major ongoing health problems, you might be suitable.

To be considered, you need to be at least 18 years old. There isn't an upper age limit mentioned, so older men might also be able to join, as long as they are healthy. Both younger and older men who meet the other health requirements may be able to participate.

It's important to remember that 'healthy' means different things in medical studies, so even if you feel well, the study doctors will do thorough checks to make sure this study is right for you and won't put your health at risk. They'll also check for any conditions that might affect how your body handles the study drug.

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 male?
Are you 18 years old or older?
Do you generally consider yourself to be in good health?
Do you have no major ongoing health conditions?
Are you willing to attend multiple clinic visits and undergo assessments?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be given a small dose of the study drug, BAY 3283142, which has a special, safe label on it to help doctors track it. You will need to attend several visits at a clinic. During these visits, the doctors and nurses will carry out various assessments. This typically includes physical examinations, having your blood and urine taken, and possibly some scans to see where the medicine goes in your body and how it's being processed and removed. The study will involve careful monitoring over a specific period, but the total duration isn't mentioned in detail here. You will be kept informed about what to expect at each stage and how long each part of your involvement will be.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit is contributing to medical science and helping to develop new treatments for conditions like chronic kidney disease. This study involves a 'radioactively labeled' substance, which means it will use a very small, safe amount of radiation to track the drug; the study team will fully explain any associated risks. As with any new medicine, there's always a chance of side effects, which will be carefully monitored. You have the right 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
Netherlands

Common questions

What does 'radioactively labeled' mean?

It means a tiny, safe amount of a special substance is added to the drug. This acts like a tracker, allowing doctors to follow the drug's journey through your body without harming you.

Why are only men being studied?

Sometimes early studies, like this one, focus on a specific group to get clear information about how a drug works before expanding to other groups, for example, women or people with kidney conditions.

Will this drug help my chronic kidney disease if I have it?

No, this study is for healthy people and is not testing if the drug treats kidney disease. It's simply looking at how the drug behaves in the body. If you have chronic kidney disease, this study is not for you.

Will I get paid for taking part?

This information isn't provided here, but many early-phase studies offer payment or cover expenses for your time and travel. This is a good question to ask the study team if you're interested.

How long will I need to be involved in the study?

The full duration isn't specified here, but early-phase studies can involve several visits over weeks or months. The study team will give you a clear timeline before you agree to take part.