NCT01884558

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

A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin

• 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 multiple doses of isavuconazole on the pharmacokinetics of a single dose of metformin. Safety and tolerability of isavuconazole will be assessed alone and in combination with metformin.

Detailed description

Subjects will check-in to the clinic on Day -1 and remain confined through completion of the study procedures on Day 10. A follow-up telephone call will be made on Day 16 to check on health status.

Conditions

• Pharmacokinetics of Isavuconazole
• Pharmacokinetics of Metformin
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	isavuconazole	oral
DRUG	metformin	oral

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-06-24
• Last updated: 2013-06-24

Locations

1 site across 1 country: United States