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.
Age range
1 Year – 17 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Pharmacokinetics (PK) of isavuconazole in plasma: Cmax at steady state
Timeframe: Up to 7 days
PK of isavuconazole in plasma: AUCtau
Timeframe: Up to 7 days
PK of isavuconazole in plasma: tmax
Timeframe: Up to 7 days
PK of isavuconazole in plasma: Ctrough
Timeframe: Up to 28 days
PK of isavuconazole in plasma: CL
Timeframe: Up to 28 days
PK of isavuconazole in plasma: Vss
Timeframe: Up to 28 days
PK of isavuconazole in plasma: AUCss
Timeframe: Up to 28 days
PK of isavuconazole in plasma: t 1/2
Timeframe: Up to 28 days
Safety assessed by nature, frequency and severity of Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to 58 days
Number of patients with vital sign abnormalities and/or adverse events
Timeframe: Up to 28 days
Number of patients with laboratory value abnormalities and/or adverse events
Timeframe: Up to 28 days
Safety assessed by routine 12- lead electrocardiogram (ECG)
Timeframe: Up to 28 days