Pediatric Trials

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.

Lead Sponsor:

Daiichi Sankyo, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Edoxaban low dose
  • Drug: Edoxaban high dose

Phase:

Phase 1

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

Ages Eligible for Study

N/A - 18 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting