Phase 1
Completed N=66
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
Source: ClinicalTrials.gov NCT02303431 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Pharmacokinetic Parameter of Apparent Systemic Clearance (CL/F) — 42.9 L/h
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Parameter of Apparent Systemic Clearance (CL/F) |
42.9 | — |
| PRIMARY Pharmacokinetic Parameter of Apparent Volume of Distribution (V/F) |
198 | — |
| SECONDARY Pharmacodynamic Parameter Mean Prothrombin Time (PT) |
13.3; 13.5; 14.0; 13.9; 14.6; 13.7 | — |
| SECONDARY Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT) |
24.1; 26.0; 33.9; 32.7; 34.3; 40.7 | — |
| SECONDARY Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa) |
0.1; 0.1; 0.1; 0.1; 0.1; 0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Is a pediatric subject requiring anticoagulant therapy
- Will abstain from the use of nonsteroidal anti-inflammatory drugs (such as ibuprofen), and other antiplatelet and anticoagulant agents (except for aspirin) from 24 hours prior to edoxaban dose until after the last PK sample is collected
- Will follow food and concomitant medication restrictions
Exclusion Criteria
- Any major or clinically relevant unexplained bleeding during prior anticoagulant therapy
- History of abnormal bleeding or coagulation within last 6 months prior to study drug administration
- Renal function with glomerular filtration rate (GFR) less than 50% of normal for age and size
- Malabsorption disorders (e.g., cystic fibrosis or short bowel syndrome)
- Hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk, alanine transaminase (ALT) > 5 times the upper limit of normal (ULN) or total bilirubin > 2 times the ULN with direct bilirubin > 20% of the total
Data sourced from ClinicalTrials.gov (NCT02303431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.