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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
IV infusion
Oral
Miller Children's Hospital
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Pharmacokinetics (PK) of isavuconazole in plasma: Cmax at steady state
Maximum concentration at steady state (Cmax) will be derived from the PK plasma samples collected.
Time frame: Up to 7 days
PK of isavuconazole in plasma: AUCtau
Area under the concentration time curve from the time of dosing to the start of next dosing interval at multiple dose conditions (AUCtau) will be derived from the PK plasma samples collected.
Time frame: Up to 7 days
PK of isavuconazole in plasma: tmax
Time of maximum concentration (tmax) will be derived from the PK plasma samples collected.
Time frame: Up to 7 days
PK of isavuconazole in plasma: Ctrough
Concentration - trough level (Ctrough) will be derived from the PK plasma samples collected.
Time frame: Up to 28 days
PK of isavuconazole in plasma: CL
Clearance (CL) will be model-derived.
Time frame: Up to 28 days
PK of isavuconazole in plasma: Vss
Volume of distribution at steady state (Vss) will be model-derived.
Time frame: Up to 28 days
PK of isavuconazole in plasma: AUCss
Area under the concentration-time curve at steady state (AUCss) will be model-derived.
Time frame: Up to 28 days
PK of isavuconazole in plasma: t 1/2
Half-life (t1/2) will be model-derived.
Time frame: Up to 28 days
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CHOC Children's Hospital of Orange County
Orange, California, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Children's Mercy Kansas City
Kansas City, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 6 more locations
Safety assessed by nature, frequency and severity of Treatment Emergent Adverse Events (TEAEs)
A TEAE is defined as an Adverse Event (AE) observed after starting administration of the study drug through follow-up. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Number of patients with TEAE's will be summarized.
Time frame: Up to 58 days
Number of patients with vital sign abnormalities and/or adverse events
An abnormality identified during a medical test (e.g. vital signs) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.
Time frame: Up to 28 days
Number of patients with laboratory value abnormalities and/or adverse events
An abnormality identified during a medical test (e.g. laboratory parameter) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.
Time frame: Up to 28 days
Safety assessed by routine 12- lead electrocardiogram (ECG)
Standard 12-lead ECG recordings will be used for the purposes of safety assessment. A 12-lead, resting ECG is to be recorded. Patients should remain supine for at least 5 minutes prior to all ECGs being performed. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded.
Time frame: Up to 28 days