NCT01813461

Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects

A Phase 1 Open-Label Mass Balance Study to Evaluate the Pharmacokinetics of Isavuconazole After a Single Oral Dose of 14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (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 evaluate the pharmacokinetics of 14C-labeled isavuconazole and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.

Detailed description

Subjects will be admitted to and stay in a clinical research unit for 23 days. On Day 1, they will receive a single oral dose of BAL8557 and throughout the study period the excretion and metabolism of the study drug will be monitored.

Conditions

• Pharmacokinetics of 14C-labeled Isavuconazole
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	14C-labeled prodrug isavuconazonium sulfate	oral

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2013-03-19
• Last updated: 2013-03-19

Locations

1 site across 1 country: United States