NCT01657838

Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects

A Phase 1, Randomized, Open-Label, Two-Arm, Parallel Group Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of ketoconazole at steady state on the pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.

Conditions

• Pharmacokinetics of Isavuconazole
• Pharmacokinetics of Ketoconazole
• Healthy Adult Volunteers

Interventions

Type	Name	Description
DRUG	Isavuconazole	oral
DRUG	Ketoconazole	oral

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-08-06
• Last updated: 2015-09-01

Locations

1 site across 1 country: United States