NCT01406171

Drug Interaction Study of Isavuconazole and Midazolam

A Phase 1, Open-Label, Drug Interaction Study of the Pharmacokinetics of Isavuconazole and Midazolam After Separate and Concomitant Administration to Healthy Adult Subjects

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

Summary

The purpose of this study is to determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects.

Detailed description

Subjects will check-in on Day -1 and remain confined to the study center until the completion of study procedures on Day 14. Subjects will return to the study center for an outpatient follow-up visit on Day 21. Blood and urine samples will be taken at various times during the study. Subjects will receive a single dose of oral midazolam syrup on Day 1. On Days 3 and 4, isavuconazole will be dosed orally three times daily (TID). On Days 5 through 13, isavuconazole will be dosed orally once daily (QD). A single dose of oral midazolam syrup will be administered on Day 12.

Conditions

• Pharmacokinetics of Isavuconazole
• Pharmacokinetics of Midazolam
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Isavuconazole	oral
DRUG	Midazolam	Oral

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-08-01
• Last updated: 2011-08-01

Locations

1 site across 1 country: United States