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Study on the Interaction Between Rivaroxaban and Sotorasib in Healthy Individuals

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What is this study about?

This clinical trial is focused on understanding how two medications, Rivaroxaban and Sotorasib, interact with each other in the body. Rivaroxaban is a medication commonly used to prevent blood clots, while Sotorasib is used in the treatment of certain types of cancer. The study involves healthy individuals to see how the body processes these drugs when taken together and separately.

The main goal of the study is to assess how the body absorbs and processes a single dose of Rivaroxaban when Sotorasib is present in the body at a steady level. Participants will take these medications orally, in the form of film-coated tablets. The study will also look at the safety of taking these medications together, using a standard method to evaluate any side effects.

Participants will be involved in the study for a period of time, during which they will take the medications and have their health monitored. The study aims to provide valuable information on the interaction between these two drugs, which could help in understanding their combined effects in the body. This information is important for ensuring the safe use of these medications in the future.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your health condition will be assessed to ensure you meet the study criteria. This includes a review of your medical history and a physical examination.

You will be asked to sign an Informed Consent Form, which confirms your willingness to participate in the study and your understanding of the procedures involved.

2 baseline assessment

A baseline assessment will be conducted to record your initial health status. This may include measuring your blood pressure and pulse rate to ensure they are within normal ranges.

3 medication administration phase 1

You will receive a single dose of rivaroxaban in the form of a 20 mg film-coated tablet. This medication is taken orally.

Your body’s response to the medication will be monitored to assess how it is processed in the absence of sotorasib.

4 medication administration phase 2

You will begin taking sotorasib in the form of 120 mg film-coated tablets. The dosage will be 960 mg, taken orally, to reach a steady state in your body.

Once the steady state is achieved, you will again receive a single dose of rivaroxaban to assess how it is processed in the presence of sotorasib.

5 monitoring and follow-up

Throughout the study, your health and any side effects will be closely monitored. This is to ensure your safety and to gather data on how the medications interact.

You will be asked to attend follow-up visits where additional assessments may be conducted to evaluate the effects of the medications.

6 study completion

At the end of the study, a final assessment will be conducted to ensure your health status is stable.

You will receive information about the study’s findings and any further steps if necessary.

Who Can Join the Study?

  • The person must be between 18 and 65 years old.
  • The person should not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months before the study starts.
  • The person must have a Body Mass Index (BMI) between 18 and 30. BMI is a measure that uses height and weight to estimate body fat.
  • The person must be able and willing to sign a form that shows they understand the study and agree to participate.
  • The person should be in good health for their age, as determined by a medical history review and physical examination within 4 weeks before the study begins.
  • The person must have normal blood pressure and pulse rate, as judged by the study doctor.

Who Cannot Join the Study?

  • Participants must be healthy individuals. This means you should not have any ongoing medical conditions.
  • Participants should not be part of a vulnerable population. This generally refers to groups who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Ssyvhqndd Rlnhrwe Ulcgurdlax Mmsfhum Cklluu Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.08.2023

Trial locations

Investigated drugs:

Rivaroxaban is a medication that helps prevent blood clots. It works by blocking certain proteins in your blood that are involved in the clotting process. This can be important for people who are at risk of developing clots, which can lead to serious conditions like strokes or heart attacks. In this study, researchers are looking at how the body processes rivaroxaban when it is taken alone and when it is taken with another medication called sotorasib.

Sotorasib is a medication used to treat certain types of cancer. It works by targeting a specific protein in cancer cells that helps them grow. By blocking this protein, sotorasib can help slow down or stop the growth of cancer. In this study, researchers are examining how sotorasib affects the way the body processes another medication called rivaroxaban. This can help doctors understand if these two medications can be safely used together.

Healthy subjects – Healthy subjects are individuals who do not have any diagnosed diseases or medical conditions. They exhibit normal physiological functions and are free from symptoms that could indicate illness. These individuals are often used in clinical trials to establish baseline data or to assess the effects of a drug without the interference of existing health issues. Their participation helps researchers understand how a drug behaves in the human body under normal conditions. Healthy subjects are typically screened to ensure they meet specific health criteria before participating in a study. They serve as a control group to compare against individuals with specific medical conditions.

Trial ID:
2023-505557-41-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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