Infections

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Hematologic Diseases

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Isavuconazole

Clotrimazole

Miconazole

Antifungal Agents

Patients will receive an intravenous (IV) loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).

Patients will receive an IV loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).

Patients will receive a loading regimen of isavuconazonium sulfate by oral administration, comprising one dose every 8 hours (+/- 2 hours) on days 1 and 2 (a total of six doses), followed by once daily oral maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).

isavuconazonium sulfate - intravenous

isavuconazonium sulfate - oral

Senior Medical Director

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.

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

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Maximum concentration at steady state (Cmax) will be derived from the PK plasma samples collected.

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 of maximum concentration (tmax) will be derived from the PK plasma samples collected.

Concentration - trough level (Ctrough) will be derived from the PK plasma samples collected.

Volume of distribution at steady state (Vss) will be model-derived.

Area under the concentration-time curve at steady state (AUCss) will be model-derived.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients	NCT03241550	Hematological M...	isavuconazonium... isavuconazonium...	1 Year - 17 Years	Astellas Pharma Inc
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients	NCT03241550	Hematological M...	isavuconazonium... isavuconazonium...	1 Year - 17 Years	Astellas Pharma Inc
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients	NCT03241550	Hematological M...	isavuconazonium... isavuconazonium...	1 Year - 17 Years	Astellas Pharma Inc

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