drugset / Trial / NCT02303431
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
Non-randomizedSingle-groupOpen-labelBasic science
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.
Timeline
- Start
- 2014-11-05
- Primary completion
- 2021-09-16
- Completion
- 2021-09-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Edoxaban | Small molecule | 30 mg | — |
| Subject | Edoxaban | Small molecule | 60 mg | — |