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Safety, Tolerability and Pharmacokinetics of Milvexian in Pediatric Patients at Risk of Thromboembolic Events (28 Days to <18 Years)

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study looks at children from 28 days to less than 18 years who are at risk of Thromboembolic Events. These are situations where a blood clot forms and can travel to block a blood vessel. The medicine being tested is called milvexian, also known by its code name JNJ-70033093, taken as a film‑coated tablet by mouth.

The purpose of the study is to learn how the body handles a single dose of this medicine and whether it is safe and well tolerated in these young participants. The study is open‑label, meaning that the investigators know the medicine being given, and it is a Phase 1 trial, the first step in testing a new drug in people.

Participants will receive one tablet of the study medicine and then stay for a short period of observation during which blood samples are taken to measure the amount of medicine in the blood and how quickly it is cleared. The visit includes simple checks such as checking vital signs and asking about any side effects, and the whole process is completed in a single day.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Study Visit and Consent

    You will attend the first study visit where study staff will explain the purpose of the trial, the procedures involved, and any potential risks. You will be asked to sign a consent form confirming that you understand and agree to participate.

  2. Step 2

    Baseline Assessments

    Before receiving any medication, you will undergo baseline assessments that may include a review of your medical history, measurement of vital signs such as blood pressure and heart rate, and collection of blood samples to establish your initial laboratory values.

  3. Step 3

    Administration of Single Oral Dose

    You will be given one film‑coated tablet of milvexian to take by mouth. The exact amount of the tablet will be determined by the study protocol, but only one dose will be administered during the trial.

  4. Step 4

    Immediate Safety Monitoring

    After taking the dose, you will be observed for a short period to monitor your vital signs and to check for any immediate side effects. Study staff will remain nearby to respond quickly if any concerns arise.

  5. Step 5

    Blood Sampling for Pharmacokinetic Analysis

    A series of blood samples will be collected at several time points after the dose. These samples are used to measure the concentration of milvexian in your plasma and to calculate parameters such as Cmax (maximum concentration), tmax (time to reach maximum concentration), AUC (overall exposure), and half‑life. The exact timing of each draw will follow the study schedule.

  6. Step 6

    Follow‑Up Safety Evaluations

    You will return for one or more follow‑up visits during which study staff will repeat vital sign measurements, review any symptoms you experienced, and may take additional blood samples to ensure your safety and to complete the pharmacokinetic profile.

  7. Step 7

    Study Completion

    After the final assessments are finished, your participation in the trial will be considered complete. You will be provided with a summary of the study procedures you underwent.

Who can join the trial?

3 criteria

  • Be a pediatric participant (a child or teenager) who is at least 28 days old but younger than 18 years at the time of screening.
  • Be medically stable, meaning your recent physical exam, health history, and basic measurements such as blood pressure and heart rate (called vital signs) are all normal enough for the study.
  • Be considered at risk for venous or arterial thrombotic events, which are blood clots that can form in the veins (venous) or arteries (arterial) and could cause health problems.

Who cannot join the trial?

3 criteria

  • You cannot join if you have a new or acute thrombosis (a recent blood clot), no matter how it was diagnosed.
  • You cannot join if you have active bleeding or are at a high risk of bleeding (likely to bleed heavily).
  • You cannot join if you have taken any anticoagulant (a medicine that prevents blood clots) within the past 24 hours, except warfarin, which must be stopped at least five days before the study (washout period).
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Investigated drugs

Milvexian is an investigational oral medication being studied to see how it works in the body, how safe it is, and how well it is tolerated. It comes as a film‑coated tablet that is taken by mouth. In this trial, the drug is given as a single dose to children and teenagers who are at risk for blood clots, to understand its behavior in young patients.

What is already known about the treatment

Milvexian - Milvexian is administered as a film‑coated tablet taken orally, allowing the patient to swallow the pill with water. It is currently an investigational drug being studied in early‑phase clinical trials, including a Phase 1 study in children at risk of blood clots. The medication is intended to help prevent thromboembolic events by blocking the activity of factor XIa, a protein that helps blood clot. This makes milvexian belong to the class of oral direct factor XIa inhibitors, a type of anticoagulant.

Investigated diseases

Thromboembolic events - Thromboembolic events are occurrences where a blood clot forms in a vessel and may break off to travel elsewhere in the bloodstream. The clot can block the original vessel, reducing blood flow to the affected area. If the clot travels, it can become an embolus that blocks another vessel, such as in the lungs, brain, or limbs. The blockage can cause symptoms that worsen as the clot grows or moves. Over time, repeated clot formation can lead to chronic narrowing of vessels.
Trial detailsLast updated 11 Nov 2026
Age0-17PhasePhase ITrial ID2026-527244-40-00Protocol code70033093THR1011Estimated enrolment47 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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