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

NCT02303431 PHASE1 COMPLETED Results posted

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.

Details

Lead sponsor	Daiichi Sankyo
Phase	PHASE1
Status	COMPLETED
Enrolment	66
Start date	Wed Nov 05 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Sep 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Deep Vein Thrombosis
• Venous Thromboembolism

Interventions

• Edoxaban low dose
• Edoxaban high dose

Countries

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