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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to learn more about how BAY3283142 moves into, through, and out of the body of healthy participants when taken together with atazanavir and to assess the proportion of BAY3283142 that reaches the blood when taken by mouth.

This study is a first look at a new medicine called BAY3283142. It's designed for healthy people to help us understand how the medicine behaves in the body. Specifically, researchers want to see how it's absorbed, how it moves around, and how it leaves the body when taken alongside another medicine called atazanavir. A key part of the study is measuring how much of BAY3283142 actually gets into the bloodstream after someone takes it by mouth. This type of study is called a 'Phase I' trial and is a very early step in developing new medicines. It helps scientists learn important information about how a medicine works before it's tested in people with specific health conditions.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Bayer AG
Enrolment target
15
Start
19 Jul 2024

What is this study about?

This research study is about a new medicine called BAY3283142. When doctors are developing a new medicine, they need to understand how it works in the human body. This study is one of the very first steps in that process.

The main aim is to carefully watch what happens to BAY3283142 when healthy people take it. We want to learn how it gets into your body after you swallow it, how it travels through your system, and how your body eventually gets rid of it. We'll also be giving participants another medicine called atazanavir at the same time to see if that changes how BAY3283142 behaves.

Understanding these things is really important. It helps scientists figure out the right amount of medicine to give and how often to give it. This information is crucial before the medicine can be tested in people who might benefit from it for conditions like chronic kidney disease in later studies.

Key takeaways

  • New medicine (BAY3283142) being tested for the first time in healthy people.
  • Aims to understand how the medicine travels through the body.
  • Will be taken with another medicine, atazanavir.
  • Important for figuring out safe and effective doses for future studies.
  • Open to healthy adults aged 18 and over, both men and women.

Who may be eligible?

This study is for healthy people who are 18 years old or older. There is no upper age limit, meaning older adults can also take part if they are otherwise healthy.

Both men and women are welcome to join this study. The researchers are looking for people who are generally healthy and don't have any major medical conditions that might affect how the study medicine works or how their body handles it.

Before you can join, a study doctor will carefully check your health to make sure it's safe for you to take part.

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 18 years old or older?
  2. Are you generally healthy with no major long-term illnesses?
  3. Are you willing to take a new medicine and another medicine at the same time?
  4. Are you able to attend clinic appointments for tests like blood samples?
  5. Are you comfortable with the possibility of side effects?
  6. Are you able to understand and follow study instructions?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given the new medicine, BAY3283142, by mouth, along with another medicine called atazanavir. You will need to attend the study clinic for appointments where doctors and nurses will monitor your health and take samples. This will involve regular blood tests to see how the medicine is moving through your body. You might also have other checks, like measuring your heart rate or blood pressure. The total number of visits and the overall length of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and potential risks. You might not directly benefit from this study, but your participation will help doctors learn important information about this new medicine, which could help others in the future. Potential risks could include side effects from the medicines, discomfort from blood tests, or unforeseen reactions. You will be closely monitored, and medical staff will be available to answer any questions or concerns. Remember, 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
    Netherlands

Common questions

What is the new medicine called?

The new medicine being studied is called BAY3283142.

Who can take part in this study?

Healthy men and women aged 18 years and older can take part.

What is the purpose of this study?

The study aims to understand how BAY3283142 moves through and leaves the body, especially when taken with another medicine called atazanavir.

Will I have to stay in a clinic?

The study description doesn't say, but you will need to attend the study clinic for appointments and tests.

What is a 'Phase I' study?

It's a very early study to learn how a new medicine works in healthy people before testing it in patients with a specific illness.

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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