Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
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.
Stanford is currently accepting patients for this trial.
Daiichi Sankyo, Inc.
- Drug: Edoxaban low dose
- Drug: Edoxaban high dose
- 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
- Any major or clinically relevant unexplained bleeding during prior anticoagulant
- History of abnormal bleeding or coagulation within last 6 months prior to study drug
- Renal function with glomerular filtration rate (GFR) less than 50% of normal for age
- 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
Ages Eligible for Study
N/A - 18 Years
Genders Eligible for Study