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Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study

NCT02303431 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-10-11

Study results available
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Summary

This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.

Conditions

  • Deep Vein Thrombosis
  • Venous Thromboembolism

Interventions

DRUG

Edoxaban low dose

Edoxaban low dose

DRUG

Edoxaban high dose

Edoxaban high dose

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-05
Primary Completion
2021-09-16
Completion
2021-09-16

Countries

  • United States
  • Canada
  • France
  • India
  • Italy
  • Lebanon
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02303431 on ClinicalTrials.gov