Drug Interaction Study of Isavuconazole and Digoxin



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:March 2012
End Date:May 2012

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A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Digoxin in Healthy Adult Subjects

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
pharmacokinetics of a single dose of digoxin in healthy adult subjects.


Inclusion Criteria:

- The subject has a body weight of at least 45 kg and has a body mass index (BMI) of
18.0 to 32.0 kg/m2, inclusive

- Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must
be ≤ upper limit of normal and total bilirubin must be ≤ 1.5 mg/dL

- 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 agrees 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 or 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 digoxin or 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 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 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
We found this trial at
1
site
Baltimore, Maryland 22125
?
mi
from
Baltimore, MD
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