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Drug Interaction Study of Isavuconazole and Warfarin in Healthy Male Subjects

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics of Isavuconazole; Pharmacokinetics of S- and R-warfarin; Pharmacodynamics of Warfarin; Healthy Volunteers

Intervention: Isavuconazole (Drug); Warfarin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Astellas Pharma Global Development, Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma Global Development


The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of warfarin after single dose administration.

Clinical Details

Official title: A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Warfarin in Healthy Male Subjects

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Composite of Pharmacokinetic (PK) variables for S-warfarin (in plasma): AUCinf, AUClast, Cmax

Secondary outcome:

Composite of PK variables for R-warfarin (in plasma): AUCinf, AUClast, Cmax

Composite of Pharmacokinetic (PK) variables for S-warfarin and R-warfarin (in plasma): tmax, Vz /F, CL/F, and t1/2

PK variable for isavuconazole (in plasma): trough concentration (Ctrough)

Composite of PK variable for isavuconazole (in plasma): AUCtau , Cmax, and tmax

Pharmacodynamic Variables: MAXINR, AUCINR, MAXPT, and AUCPT

Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) physical examinations, and vital signs

Detailed description: Subjects will receive a single dose of warfarin on Day 1 followed by a 15 day wash-out period (time from warfarin dosing to isavuconazole dosing). On Days 16 and 17, isavuconazole will be dosed three times daily (TID). TID doses will be administered 8 hours apart. On Days 18 through 28, isavuconazole will be administered once daily (QD). All subjects will be administered a single dose of warfarin on Day 20. A follow up visit will occur approximately 7 days after the last dose of isavuconazole. Blood samples for pharmacokinetics will be collected throughout the study.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.


Inclusion Criteria:

- Subjects must have BMI of 18 to 32 kg/m2 and a body weight of at least 45 kg

- Subjects must have normal laboratory values especially for ALT, AST, protein C and

S, and prothrombin time 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 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

- The subject has received an experimental agent within 30 days or 5 half-lives,

whichever is longer prior to Day - 1

- 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

Locations and Contacts

Spaulding Clinical, West Bend, Wisconsin 53095, United States
Additional Information

Starting date: June 2012
Last updated: August 27, 2012

Page last updated: August 23, 2015

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