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COMPLETEDPHASE1

Drug Interaction Study of Isavuconazole and Warfarin in Healthy Male Subjects

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

NCT01657825•Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

Summary

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.

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.

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

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 (1)

Spaulding Clinical

West Bend, Wisconsin, United States

Key Dates

Start Date

June 1, 2012

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

August 28, 2012

Enrollment

ACTUAL participants

Conditions

Pharmacokinetics of IsavuconazolePharmacokinetics of S- and R-warfarinPharmacodynamics of WarfarinHealthy Volunteers

Interventions

Isavuconazole

DRUG

Warfarin

DRUG

Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion

NCT01635972

Pharmacokinetics of IsavuconazolePharmacokinetics of Bupropion+1 more

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COMPLETEDPHASE1

Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole

NCT01660477

Pharmacokinetics of IsavuconazolePharmacokinetics of Lopinavir/Ritonavir+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Drug Interaction Study of Isavuconazole and Warfarin in Healthy Male Subjects

Inclusion Criteria

Exclusion Criteria

Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion

Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole

A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole

Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone