Phase 1 Pediatric PK/PD Study

Status: Recruiting
Phase:
DFCI Protocol ID:

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.

Conducting Institutions:

Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:

Cameron Trenor, MD, Children's Hospital Boston

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria:

  -  Pediatric subjects requiring anticoagulant therapy

  -  Male or female patients 0 to less than 18 years of age at teh time of the follow-up
     visit

  -  Patients must agree to abstain from the use of nonsteroid anti-inflammatory drugs
     (such as ibuprofen), aspirin,and other antiplatelet and anticoagulant agents from 24
     hours prior to edoxaban dose until after the last PK sample is collected

  -  Patients must agree to 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 6 months prior to study drug
     administration

  -  Renal function with GFR less than 50% of normal for age and size

  -  Patients with malabsorption disorders (eg, cystic fibrosis or short bowel syndrome)

  -  Hepatic disease associated with coagulopathy leading to a clinically relevant
     bleeding risk or alanine transaminase (ALT) > 5 time the upper limit of normal (ULN)
     or total bilirubin > 2 times the ULN with direct bilirubin > 20% of the total

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