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Study on the Interaction Between Rivaroxaban and Sotorasib in Healthy Individuals

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

2 criteria

  • 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.
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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.

What is already known about the treatment

  • Rivaroxaban

    Rivaroxaban is taken orally in the form of a tablet and is used to prevent blood clots in conditions like atrial fibrillation or after certain surgeries. It is well-established in medical practice and literature as an anticoagulant, meaning it helps prevent the formation of harmful blood clots. Rivaroxaban works by inhibiting a specific protein in the blood called Factor Xa, which is crucial for blood clotting. It belongs to a class of medications known as direct oral anticoagulants (DOACs).

  • Sotorasib

    Sotorasib is administered orally in tablet form and is primarily used in the treatment of certain types of cancer, specifically non-small cell lung cancer with a specific genetic mutation. It is a newer medication in the field of oncology and is gaining recognition in medical literature. Sotorasib works by targeting and inhibiting a protein called KRAS G12C, which is involved in the growth and spread of cancer cells. It is classified as a targeted cancer therapy, focusing on specific molecular changes in cancer cells.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505557-41-00Estimated enrolment22 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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