ED0157: Phase 1 Pediatric PK/PD Study

A Phase I, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients

Categories:

Hematological Disorders

Phase I/II

Diseases Treated:

For patients at risk for blood clots

Eligibility Overview:

  • Participant has a diagnosis requiring anticoagulant therapy.
  • Participant has completed their standard anticoagulant therapy.
  • Participant is not receiving active therapy for a malignant condition.
  • Participant is less than 18 years of age at the time of consent.
  • Participant and legal guardian agree to food and drug restrictions during study.

Description

Edoxaban is an investigational medicine that may reduce blood clots, however, it is considered experimental because it is still being studied and has not yet been approved by the United States Food and Drug Administration (FDA).

Researchers want to understand more about how the body processes and responds to Edoxaban and they would like to measure that by examining blood samples provided by study participants. In this study all participants will receive a one-time dose of the medication, and they will be divided into groups according to age and how much or how little drug they receive. Each participant will be in the study for 2-4 weeks and will have up to 3 visits (screening, Check-In, Follow up) to the study clinic.

Objectives

  • To learn about the pharmacokinetics of Edoxaban in your body.
  • To lean about the pharmacodynamics of your body after taking Edoxaban .
  • To learn about the safety of taking Edoxaban.

Eligibility criteria, among others, include:

  • Participant has a diagnosis requiring anticoagulant therapy.
  • Participant has completed their standard anticoagulant therapy.
  • Participant is not receiving active therapy for a malignant condition.
  • Participant is less than 18 years of age at the time of consent.
  • Participant and legal guardian agree to food and drug restrictions during study.

Principal Investigator

Jeremie Estepp, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.