Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT03241550
Status:
COMPLETED
Last Update Posted:
2024-11-19
First Post:
2017-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Sponsor:
Astellas Pharma Global Development, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: