A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

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.