A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

Phase 1 Completed 49 enrolled Astellas Pharma Global Development, Inc. Basilea Pharmaceutica International Ltd · collab

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2017-10-02
Primary completion: 2019-07-05
Completion: 2019-07-05

Publications

Arrieta AC, Neely M, Day JC, Rheingold SR, Sue PK, Muller WJ, Danziger-Isakov LA, Chu J, Yildirim I, McComsey GA, Frangoul HA, Chen TK, Statler VA, Steinbach WJ, Yin DE, Hamed K, Jones ME, Lademacher C, Desai A, Micklus K, Phillips DL, Kovanda LL, Walsh TJ. Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients. Antimicrob Agents Chemother. 2021 Jul 16;65(8):e0029021. doi: 10.1128/AAC.00290-21. Epub 2021 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isavuconazonium	Small molecule	10 mg/kg	Intravenous

A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

Summary

Timeline

Publications

Drugs

Indications