Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to learn how BAY2927088 is taken up and handled by the body in healthy male participants

This research study is investigating an experimental medicine called BAY2927088 in healthy men. The main goal is to understand how the body deals with this medicine once it's taken. This means researchers will be looking at how well it's absorbed, how it travels around the body, and how it’s eventually removed. This type of early study is crucial for learning about new medicines before they are tested in people who are unwell. Although this specific study is in healthy volunteers, the medicine is being developed for people with advanced non-small cell lung cancer that has specific genetic changes called EGFR or HER2 mutations. Understanding how the healthy body processes the medicine is an important first step in its development.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer AG, Bayer AG

Enrolment target

Start

04 Oct 2023

Advanced non-small cell lung cancer with EGFR and/or HER2 mutations

What is this study about?

Imagine your body as a complex machine. When you take a medicine, your machine processes it in different ways. This study, which is in a very early stage of research, is designed to understand exactly how a new medicine called BAY2927088 is handled by the body of healthy men. Researchers want to find out how much of the medicine gets into the bloodstream, how long it stays there, and how the body breaks it down and gets rid of it.

This kind of study is called a 'Human Pharmacology - Phase I' study. It's often one of the very first times a new medicine is given to people. The information gathered from healthy volunteers is really important for setting safe doses and understanding how the medicine might work in people with the condition it's designed to treat. While this study is in healthy men, BAY2927088 is being developed as a potential treatment for a type of advanced lung cancer called non-small cell lung cancer, specifically in people whose cancer has certain genetic changes known as EGFR or HER2 mutations.

By carefully studying how the healthy body reacts to BAY2927088, scientists can learn a lot about how it might work and be tolerated. This knowledge is a vital step in the long process of developing new treatments and ultimately helps to decide if and how this medicine should be studied further in patients who might benefit from it.

Key takeaways

This is an early-stage study of a new medicine called BAY2927088.
It aims to understand how the medicine is absorbed, processed, and removed by the body.
Only healthy men aged 18 and over can join this specific study.
The medicine is being developed for certain types of advanced lung cancer.
Participation involves taking the medicine and having regular health checks.
You can stop participating at any point if you wish.

Who may be eligible?

This study is looking for healthy men to take part. The main requirement for joining is that you must be at least 18 years old. There is no upper age limit specified, so men of all adult ages could potentially participate.

It's important that participants are in good general health, as this helps researchers understand how the medicine works in a typical body without other health issues complicating the results. Specific health checks will be carried out to make sure you are suitable and in good health before you can join the study.

More detailed information about other requirements, such as your medical history or any medicines you might be taking, would be discussed with the study team if you express interest. These checks ensure your safety and that the study results are clear and accurate.

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 a man?
Are you 18 years old or older?
Are you generally in good health?
Are you willing to follow study instructions and attend appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have a screening visit first to check your health and make sure you meet all the requirements. If you are suitable, you would then attend study visits where you would receive the study medicine, BAY2927088. This medicine would likely be given as a tablet or capsule. You would be closely monitored by doctors and nurses to see how you react to the medicine.

During these visits, you would have various assessments. These might include blood tests, urine tests, checking your heart rate and blood pressure, and possibly other tests to see how the medicine is being processed by your body. The researchers would be particularly interested in taking blood and urine samples at specific times after you take the medicine to measure the levels of BAY2927088. You would also be asked about any side effects you might experience.

The overall length of your participation would depend on the study design, including how many doses you receive and how long you are monitored afterwards. You would be given a detailed schedule explaining all the visits and procedures before you agree to join.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. One potential benefit is contributing to medical science and helping to develop new treatments for serious diseases like lung cancer. You would also receive careful medical monitoring throughout the study. However, as this is an early-stage study of a new medicine, there is a risk of experiencing side effects that are not yet well understood. These could be mild, like feeling sick or tired, or more serious. The study team will explain all known risks to you. You are free 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 is BAY2927088?

It's a new, experimental medicine being developed to treat a type of lung cancer, but in this study, we are testing how it works in healthy men.

Why are you testing it in healthy men if it's for cancer patients?

Testing in healthy volunteers helps us understand how the body processes the medicine safely and effectively before giving it to people who are unwell. It's an important first step.

Will I get cancer treatment if I join this study?

No, this study is not a treatment for cancer. It's about understanding how the new medicine works in healthy people.

What kind of tests will I have if I join?

You'll likely have blood tests, urine tests, heart rate and blood pressure checks, and other general health assessments to monitor how your body reacts to the medicine.

Can I leave the study if I change my mind?

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