NCT01657825

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics of Isavuconazole
• Pharmacokinetics of S- and R-warfarin
• Pharmacodynamics of Warfarin
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Isavuconazole	oral
DRUG	Warfarin	oral

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-08-06
• Last updated: 2012-08-28

Locations

1 site across 1 country: United States