NCT03241550

A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematological Malignancy

Interventions

Type	Name	Description
DRUG	isavuconazonium sulfate - intravenous	IV infusion
DRUG	isavuconazonium sulfate - oral	Oral

Timeline

• Start date: 2017-10-02
• Primary completion: 2019-07-05
• Completion: 2019-07-05
• First posted: 2017-08-07
• Last updated: 2024-11-19

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study