Study of the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects

All subjects receive a single dose of isavuconazole on Day 1 under fasting conditions.
Subjects are confined to study center from Day -1 until Day 4 when they are discharged.
Subjects return for outpatient visits on Days 6, 8, 11, 13 and 15.

Inclusion Criteria:

- Subjects are healthy, non-elderly males and females between 18 and 45 years and
healthy, elderly males and females 65 years of age and older

- The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18
to 32 kg/m2, inclusive

- The estimated (calculated) creatinine clearance must be within the age-appropriate
normal range, if abnormal, the abnormality is not clinically significant, as
determined by the Investigator

- Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), and
total bilirubin must be within the normal range

- The Female subject agrees to sexual abstinence, or is surgically sterile,
postmenopausal (defined as at least 2 years at Screening without menses), or using a
medically acceptable double barrier method (e.g. spermicide and diaphragm, or
spermicide and condom) to prevent pregnancy and agree to continue using this method
from Screening until 3 weeks after the follow-up visit at the end of the study; and
is not lactating or pregnant as documented by negative pregnancy tests at Screening
and Day -1

- The Male subject agrees to sexual abstinence, is surgically sterile, or is using a
medically acceptable method to prevent pregnancy and agrees to continue using this
method from Screening until 3 weeks after the follow-up visit at the end of the study

Exclusion Criteria:

- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac
arrhythmia or torsade de pointes, structural heart disease, or family history of Long
QT syndrome (suggested by sudden death of a close relative at a young age due to
possible or probable cardiac causes)

- The subject has a positive result for hepatitis C antibodies, hepatitis B surface
antigen at Screening or is known to be positive for human immunodeficiency virus
(HIV)

- The subject has a known or suspected allergy to any of the components of the trial
products including the azole class of compounds, or a history of multiple and/or
severe allergies to drugs or foods (as judged by the investigator), or a history of
severe anaphylactic reactions

- The subject is a smoker (any use of tobacco or nicotine containing products) within 6
months prior to Screening

- The subject, if non-elderly, has had treatment with prescription drugs or
complementary and alternative medicines within 14 days prior to Day -1, or
over-the-counter medications within 1 week prior to Day -1, with the exception of
acetaminophen up to 2 g/day

- The subject, if elderly, has not been on stable concomitant medications (minor
necessary dosing changes are acceptable) for at least 4 weeks prior to study drug
administration or is taking any medication that would interfere with the evaluation
of isavuconazole in this study (CYP3A4 inducer or inhibitor)

- The subject has a recent history (within the last 2 years) of drug or alcohol abuse,
as defined by the investigator, or a positive drug and/or alcohol screen