Drug Interaction Study of Isavuconazole and Warfarin in Healthy Male Subjects

Completed · Phase 1

Conditions studied: Pharmacokinetics of Isavuconazole, Pharmacokinetics of S- and R-warfarin, Pharmacodynamics of Warfarin, Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01657825

Run by

Astellas Pharma Global Development, Inc.

People needed

20

Starts

2012-06-01

Expected to finish

2012-07-01

Last updated by the study team

2012-08-28

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Spaulding Clinical — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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