NCT02303431

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

A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase 1, open-label, multiple-center study in pediatric patients from 0 to \< 18 years of age. Patients will receive a single dose of edoxaban to match either the 30 mg (low dose) or the 60 mg (high dose) exposure in adults. Exact doses will be selected during the study on the basis of PK modeling of emerging data. If unanticipated exposures are observed, the target doses may be modified to best match expected exposure response relationships observed in adults. Enrollment in the study will start with the low dose, highest age group (adolescents) and will continue from low to high dose in each age group and from higher to lower age groups. Enrollment in the next dose/age cohort will begin after 50% of the subjects have completed the previous dose/age cohort. Age cohorts and dose groups: (6 participants each in low and high dose groups, for a total of 12 participants per age cohort) * 12 to \< 18 years of age * 6 to \<12 years of age * 2 to \<6 years of age * 6 months to \<2 years of age * 0 to \<6 months of age

Conditions

• Deep Vein Thrombosis
• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Edoxaban low dose	Edoxaban low dose
DRUG	Edoxaban high dose	Edoxaban high dose

Timeline

• Start date: 2014-11-05
• Primary completion: 2021-09-16
• Completion: 2021-09-16
• First posted: 2014-12-01
• Last updated: 2023-10-11
• Results posted: 2023-10-11

Locations

35 sites across 9 countries: United States, Canada, France, India, Italy, Lebanon, Spain, Turkey (Türkiye), United Kingdom