Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to learn how asundexian affects the amount of metformin in the blood when healthy participants take them together

This study is designed to understand how a new medicine called asundexian works when healthy people take it at the same time as metformin, a medicine often prescribed for diabetes. Specifically, we're looking at how asundexian might change the amount of metformin in your bloodstream. This kind of research, called human pharmacology (Phase I), is an early step in developing new medicines. It helps us learn important things about how drugs interact and if they are safe when used together. The main goal here isn't to treat a specific illness, but to understand the fundamental way these two medicines behave in the body, which is crucial for future research.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer AG

Enrolment target

Start

31 May 2024

Prevention of ischemic stroke in patients after an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack in combination with antiplatelet therapy

What is this study about?

This study is about a new medicine called asundexian. We want to understand how it behaves in the body, especially when someone also takes metformin, a common medicine for diabetes. In this study, healthy volunteers will take both medicines, and doctors will carefully check how much metformin is in their blood. This helps us see if asundexian changes how the body handles metformin.

Studies like this are very early steps in developing new medicines. They are often called 'Phase I' studies. They don't aim to treat a specific illness yet, but rather to gather important information about how the new medicine works and if it's safe when combined with other common drugs. This information is really important for doctors and scientists to decide if a new medicine can move forward to bigger studies.

The bigger picture for asundexian is that it is being investigated to help prevent serious health problems like strokes in people who have already had a type of stroke or a mini-stroke (called a transient ischemic attack) and are also taking other blood-thinning medicines. By understanding how it interacts with metformin now, we can ensure it's safe for a wider range of people in the future.

Key takeaways

This is an early-stage study (Phase I) for a new stroke prevention medicine, asundexian.
The main goal is to understand how asundexian affects metformin levels in your blood if you take them together.
Healthy adults (18+) are needed to participate.
Participation involves taking both medicines and having blood tests at clinic visits.
Your involvement helps gather important safety information for future patients.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part. This study is specifically looking for healthy volunteers, meaning people who don't have serious medical conditions.

Since this study is about how two medicines interact, you would need to be able to take both medicines as instructed by the study doctors. Full details about who can and cannot join will be given by 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?
Are you generally healthy, without any major ongoing medical conditions?
Are you able to attend regular clinic appointments as part of the study?
Are you comfortable taking new medicines as part of a research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given both the new medicine, asundexian, and metformin to take. You'll have regular visits to the study clinic where doctors and nurses will monitor your health and take blood samples. These samples will help them measure the levels of metformin in your blood. You might need to stay at the clinic for certain periods, and there will be follow-up calls or visits after you finish taking the medicines. The study will last for a specific amount of time, which the study team will explain fully before you join.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might not directly benefit from this study, as it's primarily about understanding how medicines interact. However, your participation will contribute valuable information that could help develop safer and more effective treatments for others in the future. Potential risks might include side effects from the medicines, discomfort from blood tests, or inconvenience from clinic visits. The study team will explain all known side effects and risks. Remember, 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.

—
Unverified
Germany

Common questions

What is asundexian?

Asundexian is a new medicine being studied to help prevent strokes, especially in people who have already had one. This study is an early step to learn about it.

What is metformin?

Metformin is a common medicine used to treat type 2 diabetes.

Why join this study if I'm healthy?

Even though you're healthy, taking part helps us learn how these medicines interact, which is vital for safe and effective use in patients who need them.

Will I get paid to participate?

Compensation for time and travel is often provided in studies like this. The study team will give you all the details.

What happens to my medical information?

Your privacy is very important. All your personal medical information will be kept confidential and used only for the study purposes, as explained by the research team.