NCT01657890

Study of the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects

A Phase 1, Open Label, Parallel Group, Single Dose Study to Evaluate the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics of isavuconazole in healthy non-elderly and elderly male and female subjects.

Detailed description

All subjects receive a single dose of isavuconazole on Day 1 under fasting conditions. Subjects are confined to study center from Day -1 until Day 4 when they are discharged. Subjects return for outpatient visits on Days 6, 8, 11, 13 and 15.

Conditions

• Pharmacokinetics of Isavuconazole
• Healthy Volunteers
• Safety and Tolerability in Elderly

Interventions

Type	Name	Description
DRUG	isavuconazole	oral

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-08-06
• Last updated: 2015-09-01

Locations

1 site across 1 country: United States