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Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
Recruiting
I'm InterestedTrial ID: NCT02303431
Purpose
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.
Official Title
A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients
Stanford Investigator(s)
Eligibility
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
Intervention(s):
drug: Edoxaban low dose
drug: Edoxaban high dose
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305