A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

Launched by ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC. · Aug 3, 2017

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Subject has sufficient venous access to permit administration of study drug (for the IV cohorts), collection of pharmacokinetic samples and monitoring of safety laboratories.
• * Female subject must either:
• • Be of non-childbearing potential: Clearly premenarchal or documented surgically sterile
• • Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; and have a negative urine or serum pregnancy test at screening; and, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least one of which must be a barrier method) starting at screening and throughout the study and for 28 days after the final study drug administration.
• • Female subject who is of childbearing potential must agree not to breastfeed starting at screening and throughout the study and for 28 days after the final study drug administration.
• • Female subject who is of childbearing potential must not donate ova starting at screening and throughout the study and for 28 days after the final study drug administration.
• • Male subject who is of childbearing potential and their female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least one of which must be a barrier method) starting at screening and continue throughout the study, and for 90 days after the final study drug administration.
• • Male subject who is of childbearing potential must not donate sperm starting at screening and throughout the study and, for 90 days after the final study drug administration.
• • Subject and subject's parent(s) or legal guardian agree that the subject will not participate in another interventional study while on treatment.
• • For oral cohorts: subject is able to swallow the oral capsule medication.
• Exclusion Criteria:
• • Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal electrocardiogram (ECG).
• * Subject has evidence of hepatic dysfunction defined as:
• • Total bilirubin ≥ 3 times the upper limit of normal (ULN)
• • Alanine transaminase or aspartate transaminase ≥ 5 times the ULN
• • Known cirrhosis or chronic hepatic failure
• • Subject has used strong cytochrome P450 (CYP) 3A4 inhibitors or inducers such as ketoconazole, rifampin/rifampicin, long acting barbiturates, carbamazepine and St. John's wort in the 5 days prior to the first administration of study drug.
• • Subject has known history of allergy, hypersensitivity, or any serious reaction to any of the azole class antifungals.
• • Subject has any condition which makes the subject unsuitable for study participation.
• • Subject is unlikely to survive 30 days.
• • Subject has received investigational therapy, with the exception of oncology drug trials, within 28 days or 5 half-lives, whichever is longer, prior to screening.
• • For oral cohorts: The subject has gastrointestinal disease or has had a procedure that is expected to interfere with the oral absorption or tolerance of the study drug (e.g., functionally relevant gastrointestinal obstruction, mucositis/stomatitis, or frequent vomiting).
• • Subject previously dosed with isavuconazonium sulfate.