NCT02128321

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine

A Phase 1 Open Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine

• 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 Repaglinide and possible metabolites after single dose administration. In addition, this study will assess the effect of multiple doses of isavuconazole on the pharmacokinetics of caffeine and possible metabolites after single dose administration. Safety and tolerability of isavuconazole alone and in combination with Repaglinide or in combination with caffeine will be assessed.

Conditions

• Pharmacokinetics of Repaglinide
• Pharmacokinetics of Caffeine
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Isavuconazole	oral
DRUG	Repaglinide	oral
DRUG	Caffeine	oral

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2014-05-01
• Last updated: 2014-05-01

Locations

1 site across 1 country: United States