clinical trial · NCT03241550
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Astellas Pharma Global Development, Inc.·phase1·completed·n = 49
Hematological Malignancyisavuconazonium sulfate - intravenousisavuconazonium sulfate - oral
brief summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.
started
Oct 2, 2017
primary completion
Jul 5, 2019
completion
Jul 5, 2019
last updated
Nov 19, 2024
official title
A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol