Pharmacokinetics, Pharmacodynamics, and Safety of Edoxaban in Pediatric Subjects: A Phase I Single-Dose Study

• Published in: Clinical pharmacology and therapeutics Vol. 116; no. 3; p. 736
• Main Authors: Zou, Peng, Zahir, Hamim, Duggal, Anil, Pandya, Grishma, Jin, James, Leil, Tarek A
• Format: Journal Article
• Language: English
• Published: United States 01.09.2024
• Subjects: Administration, Oral; Adolescent; Age Factors; Area Under Curve; Child; Child, Preschool; Dose-Response Relationship, Drug; Factor Xa Inhibitors - administration & dosage; Factor Xa Inhibitors - adverse effects; Factor Xa Inhibitors - pharmacokinetics; Factor Xa Inhibitors - pharmacology; Female; Humans; Infant; Infant, Newborn; Male; Pyridines - administration & dosage; Pyridines - adverse effects; Pyridines - pharmacokinetics; Pyridines - pharmacology; Thiazoles - administration & dosage; Thiazoles - adverse effects; Thiazoles - pharmacokinetics; Thiazoles - pharmacology; Venous Thromboembolism - drug therapy

This was an open-label, single-dose, phase I study to characterize the pharmacokinetics (PKs), pharmacodynamics (PDs), and safety of edoxaban in pediatric subjects from birth to 18 years at risk for venous thromboembolism (VTE). Children requiring anticoagulant therapy were enrolled into 5 age cohor...