Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.

In Part 1, eligible subjects will be enrolled into one of 2 groups based on their renal
function. All subjects will receive a single 1-hour infusion of isavuconazole and will
remain confined for 4 days. Subjects with normal renal function will return to the clinic
for several outpatient visits over 15 days after dosing. Subjects with renal disease will
complete the same outpatient visits which correspond to scheduled dialysis dates and then be
readmitted to the clinic on study Day 15 to receive a second 1-hour infusion of
isavuconazole followed by their normal dialysis procedure and then remain confined for 4
days. ECGs, vital signs, blood draws will be obtained throughout the study for safety and to
assess the amount of study drug in the body as well as study drug removed in subjects
undergoing dialysis.

In Part 2, eligible subjects will be enrolled into one of 4 groups based on their renal
function. All subjects will receive a single 1-hour infusion of isavuconazole and remain
confined for 4 days. Subjects will return to the clinic for several outpatient visits over
15 days after dosing. ECGs, vital signs, blood draws will be obtained throughout the study
for safety and to assess the amount of study drug in the body.

Inclusion Criteria:

- Subject must weigh at least 45 kg and have a body mass index of 18-35 kg/m2

- If female, the subject agrees to sexual abstinence, is surgically sterile,
postmenopausal or using a medically acceptable double-barrier method to prevent
pregnancy and agrees to continue using this method during the study and until 28 days
after final study dug administration. Female subjects must not be lactating or
pregnant as documented by a negative pregnancy test at Screening and Day -1

- If male, the 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 during the study and until 90 days after the end of the study

- The subject has good venous access

- Female subject must not donate ova starting at Screening and throughout the study
period, and for 28 days after final study drug administration.

Exclusion Criteria:

- The subject has a previous history of any clinically significant gastro-intestinal,
neurological, hepatic, pulmonary, metabolic, dermatologic, immunologic,
cardiovascular, psychiatric, genitourinary, endocrine, hematological disorder or
disease, malignancy excluding non-melanoma skin cancer or any other medical condition
that would preclude participation in the study

- The subject has evidence of any cardiac conduction abnormalities

- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac
arrhythmia, torsade de pointes, structural heart disease, or family history of Long
QT syndrome

- The subject has a supine systolic blood pressure less than 90 or greater than 160
mmHg, and diastolic blood pressure less than 50 or greater than 90 mmHg, or pulse
rate less than 40 or greater than 100 beats per minute, either at Screening and Day
-1

- The subject has a history of consuming more than 14 units of alcoholic beverages per
week, has a history of alcohol abuse within the past 2 years prior to Screening, or
has a positive screen for alcohol at Screening or Day -1. (NOTE: one unit = 12 ounces
of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor.)

- The subject has a positive test for alcohol or drugs of abuse at Screening or Day-1,
unless it is an expected result due to an approved concomitant medication for
subjects with renal impairment

- The subject has used nicotine patches or any tobacco-containing products within 1
month prior to Day-1 or is a smoker, defined as greater than 10 cigarettes per week

- The subject has had treatment with prescription drugs or complementary and
alternative medicines within 14 days prior to Screening, or over-the-counter
medication within 14 days prior to Screening (with the exception of acetaminophen up
to 2 grams/day)

- The subject anticipates an inability to abstain from caffeine or alcohol for 48 hours
prior to Day -1 and throughout the duration of the study

- The subject anticipates an inability to abstain from grapefruit, Seville oranges,
star fruit, or any products containing these items from 72 hours prior to Day -1 and
throughout the duration of the study

- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper
respiratory infection), or fungal (non-cutaneous) infection within 7 days prior to
Day -1

- The subject has been vaccinated within the last 30 days prior to Screening

- The subject has a positive test for hepatitis C antibody or hepatitis B surface
antigen at Screening or a known history of human immunodeficiency virus

- The subject has a known or suspected hypersensitivity to isavuconazole, the azole
class of compounds, or any components of the study drugs

- The subject has received an experimental agent within 30 days or ten half-lives,
whichever is longer, prior to Screening

- The subject has had any significant blood loss, donated one or more units (450 mL) of
blood or received a transfusion of any blood or blood products within 60 days or
donated plasma within 7 days prior to Day -1

- The subject has any other condition, which in the opinion of the investigator,
precludes the subject's participation in the trial