AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A study to learn about how different drugs interact with each drug in a new 7-drug mixture as they move into, through, and out of the body in healthy men

This research study is looking for healthy men to help understand a new combination of seven different medicines. The main goal is to find out how each of these medicines behaves inside the body – how they are absorbed, how they are processed, and how they eventually leave the body. We also want to see if these medicines affect each other when taken at the same time. This type of study, often called a 'drug-drug interaction' study, is an early but important step in developing new treatments. It helps make sure that when different medicines are used together, they are safe and work as expected. Your participation could help scientists learn crucial information for future patient care.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer AG

Enrolment target

Start

23 Oct 2023

drug-drug interactions (DDI)

What is this study about?

Imagine you take several medicines at once. Sometimes, one medicine can change how another medicine works in your body. This study wants to understand this process for a new group of seven different medicines that might be used together in the future. They want to see how each of these medicines gets into your body, what it does while it's there, and how it eventually leaves.

This kind of research is really important. It helps scientists learn if taking these specific medications together could cause any unexpected problems or if one medicine might stop another from working properly. By understanding these interactions early on, researchers can make sure that future combinations of medicines are as safe and effective as possible for patients.

This is an early stage of research, often called a 'Phase I' study. It focuses on how medicines move through the body in healthy volunteers rather than testing if they treat a specific illness. Your help in this study would provide valuable information for developing new treatments for others in the future.

Key takeaways

The study looks at how a new mix of seven medicines works in healthy men.
It helps us understand how medicines interact with each other in the body.
You need to be a healthy man, aged 18 or older.
Participation involves taking the study medicines and having regular health checks.
This research helps make future medicines safer and more effective.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You would need to be at least 18 years old to take part, and there isn't an upper age limit mentioned, so older men may also be able to join.

Being 'healthy' usually means you don't have any significant ongoing medical conditions, you're not taking regular medications that could interfere with the study drugs, and you don't have any severe allergies.

The research team will carry out several health checks to make sure it's safe for you to participate. This will include looking at your medical history and doing some physical examinations and tests.

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 healthy with no major ongoing medical conditions?
Are you willing to discuss your medical history and have health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the new combination of seven medicines. The study would involve several visits to a clinic over a period of time. During these visits, the research team would closely monitor your health and take samples, such as blood or urine, to see how the medicines are moving through your body. You might also have regular checks of your heart rate, blood pressure, and other vital signs.

The total duration of your involvement could vary, but these early-stage studies often involve a screening period, a dosing period where you take the medicines, and then a follow-up period to make sure you are well. All procedures and the full time commitment would be explained in detail before you agree to participate.

Potential risks and benefits

Patients who take part in research studies often feel good knowing they are helping to improve future medical treatments. While this study doesn't offer direct health benefits to you, the information gathered will be incredibly valuable for developing new, safer medicines for others. As with any medicine, there's always a chance of side effects, which could range from mild to more serious. The research team will explain all known potential risks before you decide to join. Remember, you can choose to leave 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.

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Unverified
Germany

Common questions

What does 'drug-drug interactions' mean?

It means how one medicine might affect another medicine when they are taken together, possibly changing how they work.

Will these medicines treat an illness I have?

No, this study is about understanding how the medicines work in healthy people, not about treating an illness.

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

The exact time will be explained, but this type of study often involves several clinic visits over a few weeks or months.

Will I be paid for taking part?

Sometimes studies offer payment for your time and travel, but this varies and will be explained by the study team.

What if I feel unwell during the study?

The research team will monitor you closely, and you should tell them immediately if you feel unwell or have any concerns.