Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study

• Status: Completed
• Trial end date: 2021-09-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Collaborator: Medpace, Inc.
• Treatments: Edoxaban

Criteria

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