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A Study to Assess the Safety and Tolerability of Milvexian in Pediatric Participants at Risk of Thromboembolic Events

Open-label, Multi-center, Single-dose Phase 1 Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Milvexian in Pediatric Patients From 28 Days to Less Than 18 Years of Age at Risk of Thromboembolic Events

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2024-000583-38-Outside-EU/EEA
Enrollment
Unknown
Registered
2024-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolic Events MedDRA version: 21.1 Level: LLT Classification code 10043565 Term: Thromboembolic event System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: JNJ-70033093 Product Code: JNJ-70033093 Pharmaceutical Form: Tablet INN or Proposed INN: Milvexian Current Sponsor code: JNJ-70033093 Concentration unit: mg milligram(s) Concentration ty

Sponsors

Janssen Research & Development, LLC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pediatric participants aged 28 days to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Any evidence of new or acute thrombosis no matter how diagnosed - Active bleeding or at high risk of bleeding - Received an anticoagulant within 24 hours of study intervention administration (except warfarin, which requires a 5-day washout)

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the PK of milvexian after a single dose in pediatric participants at risk of thromboembolic events (28 days to <18 years of age).;Secondary Objective: - To assess the safety and tolerability of a single dose of milvexian. - To evaluate the PD of milvexian after a single dose. - To evaluate the PK/PD relationship after a single dose of milvexian. - To assess acceptability and palatability;Primary end point(s): Plasma milvexian Cmax and AUC8;Timepoint(s) of evaluation of this end point: pre-dose, 30 to 45 minutes, 1.5 to 2.5 hour, 3 to 5 hour, 8 to 14 hours and 27 to 30 hours post-dose on Day 1—

Secondary

MeasureTime frame
Secondary end point(s): - Number of Participants with Adverse Events (AEs) and AEs of Interest (AESI) - Number of Participants with Vital Signs Abnormalities - Number of Participants with Clinically Significant Laboratory Abnormalities - Activated Partial Thromboplastin Time (aPTT) - Fold-change in Activated Partial Thromboplastin Time - Palatability And Acceptability of Milvexian Using Acceptability And Palatability Questionnaire ;Timepoint(s) of evaluation of this end point: - Up to 28 days - Up to 28 days - Up to 28 days - Baseline, Day 1: pre-dose (0 hour) - Baseline, Day 1: pre-dose (0 hour) - Day 1 post dose—

Countries

United States

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International NV

ClinicalTrialsEU@its.jnj.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026