Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to learn about the amount of asundexian in the blood when healthy participants take different types of asundexian tablets

This study is investigating a new medicine called asundexian, which is being developed to help prevent strokes. Researchers want to understand how different types of asundexian tablets are absorbed by the body. To do this, healthy volunteers will take various forms of the medicine, and scientists will measure how much asundexian is present in their blood. This is a very early stage of testing, known as a Phase 1 study, and it's a crucial step in learning about the drug's safety and how it works in the human body. The information gathered will help future studies focus on preventing strokes in people who have had a stroke or a warning sign of a stroke in the past.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer AG

Enrolment target

Start

17 May 2024

Prevention of ischemic stroke in patients post acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack

What is this study about?

This study is about a new medicine called asundexian. Doctors and scientists are looking for new ways to prevent strokes, especially in people who have had a stroke or a mini-stroke (called a TIA) before. This new medicine aims to help with that.

At this very early stage, the study isn't testing whether the medicine prevents strokes yet. Instead, it's focused on understanding how asundexian works in the body. Specifically, researchers want to see how much of the medicine gets into the blood when healthy people take different types of asundexian tablets. This is really important because it helps them figure out the best way to give the medicine in the future.

Think of it like trying out different types of packaging for a new food. You want to see which packaging best delivers the food. In this case, the 'packaging' is the tablet type, and the 'food' is the medicine getting into your system. By understanding this, scientists can develop the most effective and safest way to use asundexian to help patients.

Key takeaways

This study is for a new medicine called asundexian, aiming to prevent strokes.
It's an early-stage study (Phase 1) focused on healthy volunteers.
The main goal is to understand how different asundexian tablets are absorbed by the body.
The findings will help scientists develop the best way to use the medicine in the future.
Participation involves taking the study drug and having regular check-ups and blood tests.

Who may be eligible?

This study is looking for healthy adults aged 18 and over, regardless of whether they are male or female. You won't be able to join if you have certain health conditions or are taking particular medications, as this study needs to focus on how the new medicine works in generally healthy people.

The main idea is to include people who are well and not currently being treated for other serious health issues, especially those that might affect how medicines are absorbed or processed by the body. This helps researchers get clear results about the new medicine itself.

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 in good health?
Do you currently have any serious ongoing medical conditions?
Are you taking any regular prescription or over-the-counter medications?
Are you able to attend several study appointments as required?

Answer every question to see your result.

What does participation involve?

This study is a Phase 1 trial, which means it's one of the first times this medicine is being tested in humans. If you take part, you would likely need to visit the study clinic multiple times. During these visits, doctors and nurses will assess your health, take blood samples to measure the medicine levels, and monitor you closely. You will be given different types of asundexian tablets to take as part of the study.

The total amount of time you would be involved in the study would depend on the specific schedule, but Phase 1 studies often involve a period of close monitoring, potentially including stays at a research facility. You'll have regular check-ups, and the medical team will make sure you're feeling okay throughout. Before joining, the study team will explain everything in detail, including how long each visit might take and the full duration of your participation.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. As this is a very early study, the main benefit is contributing to medical knowledge that could eventually help prevent strokes in the future. You will also receive careful medical monitoring. Potential risks could include side effects from the study medicine, even though healthy people are involved. These side effects might be mild, like an upset stomach, or could be more serious, though serious side effects are rare and carefully watched for. You will be given a full list of known and potential side effects before you agree to take part. Remember, you can choose to leave 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
Germany

Common questions

What is asundexian?

Asundexian is a new experimental medicine that scientists are researching to see if it can help prevent strokes.

Why is this study only for healthy people?

This early stage study needs to see how the medicine works in healthy bodies first, without other health conditions making the results unclear.

Will this medicine help prevent my stroke if I join?

No, this study is about understanding the medicine, not treating stroke patients yet. It's a step towards future treatments.

What does a 'Phase 1' study mean?

Phase 1 means it's one of the first times a new medicine is given to humans, mainly to check its safety and how the body handles it.

Will I have to stay overnight for this study?

It's possible. Some Phase 1 studies require overnight stays for close monitoring. The study team will tell you all the details.