Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Rivaroxaban sotorasib interaction study (the ROSIE-study)

This research, called the ROSIE-study, is designed to understand how two commonly used medications, sotorasib (also known as LUMYKRAS) and rivaroxaban (also known as Xarelto), behave in your body when they are taken together. Rivaroxaban is often prescribed to prevent blood clots. Sotorasib is a cancer treatment. This study is for healthy volunteers and will help doctors understand if one medicine changes how the other works, specifically by looking at how much rivaroxaban is absorbed and stays in your system. This is important information to ensure people taking these medicines receive the correct and safest dose.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Stichting Radboud University Medical Center

Enrolment target

Start

01 Aug 2023

Healthy subjects

What is this study about?

The ROSIE-study is a research project focusing on how two medicines, LUMYKRAS (sotorasib) and Xarelto (rivaroxaban), interact with each other in the body. While LUMYKRAS is a treatment for certain types of cancer and Xarelto is used to prevent or treat blood clots, this particular study is being carried out with healthy volunteers, not patients with these conditions. This allows researchers to get a clear picture of how the drugs interact without other health issues complicating the results.

The main goal is to see if taking LUMYKRAS changes how much Xarelto gets into your blood and how long it stays there. Scientists measure this by looking at something called AUC (which tells them the total amount of medicine in your body over time) and Cmax (which is the highest level the medicine reaches in your blood). They will compare these measurements when Xarelto is taken alone versus when it's taken alongside LUMYKRAS. Understanding these interactions is vital because if one medicine affects the levels of another, it could mean a patient might get too much or too little of a vital drug, potentially leading to side effects or reduced effectiveness.

Beyond just the interaction, the study will also look at how LUMYKRAS itself is handled by the body in healthy people. This helps build a complete picture of the drug. Importantly, the study will carefully monitor the safety of both medicines when taken by healthy individuals, noting any side effects using a standard grading system. This information is crucial for doctors to confidently prescribe these medications, especially if a patient needs both.

Key takeaways

This study looks at how two medicines, LUMYKRAS and Xarelto, interact in healthy people.
It helps doctors understand how much of each medicine stays in your body.
Participation will involve taking study medications and having blood tests.
The study is for healthy adults, aged 18 and over, of any gender.
Your involvement helps improve future patient care, even without personal health benefits.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adults aged 18 years and older. There is no upper age limit, meaning older adults are welcome to participate if they are otherwise healthy.

Anyone, whether male or female, can take part in this research.

To be considered healthy, you would generally not have any serious ongoing medical conditions, not be taking many other medications, and be able to participate safely in the study activities.

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?
Do you consider yourself generally healthy?
Are you free from any major ongoing medical conditions?
Are you able to visit a study clinic for appointments and tests?
Are you able to take study medications as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given both LUMYKRAS tablets and Xarelto tablets at different times, as directed by the study team. You won't be treated for any illness, as this study involves healthy people. The study will involve a series of visits to the research clinic where blood samples will be taken at specific times to measure the levels of the medicines in your body. You will also have regular check-ups to make sure you are feeling well and to monitor for any side effects. The total length of your participation will be explained in detail, but it will involve several days of close observation and follow-up to collect all the necessary information.

Potential risks and benefits

Taking part in any study has potential benefits and risks. While you won't personally benefit from treatment for a disease, your participation will help doctors understand how these important medicines interact, which can improve care for many future patients. Potential risks include side effects from the medications, such as those listed for LUMYKRAS and Xarelto, though these are typically monitored very carefully. There is also the inconvenience of clinic visits and blood tests. You are free to withdraw from the study at any time and 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
Netherlands

Common questions

What is the main goal of this study?

The study aims to see how two medicines, LUMYKRAS and Xarelto, affect each other when taken together in healthy people.

Who can take part in this study?

Healthy adults aged 18 or older, both men and women, are eligible to join.

Will I be treated for an illness?

No, this study is for healthy volunteers, so you won't be treated for any specific medical condition.

What kind of tests will I have?

You'll have blood tests to measure medicine levels and regular health checks to monitor your well-being.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point without it affecting your healthcare.