Drug Interaction Study of Isavuconazole and Midazolam
The purpose of this study is to determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects.
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Midazolam
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase 1, Open-Label, Drug Interaction Study of the Pharmacokinetics of Isavuconazole and Midazolam After Separate and Concomitant Administration to Healthy Adult Subjects|
- Pharmacokinetic assessment of AUC through the analysis of blood samples [ Time Frame: Up to Day 13 ] [ Designated as safety issue: No ]
- Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples [ Time Frame: Up to Day 13 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Isavuconazole and Midazolam
Isavuconazole three times per day (TID) for 2 days followed by once a day (QD) for 9 days. Midazolam single doses on days 1 and 12
Other Names:Drug: Midazolam
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.
|United States, Wisconsin|
|Covance Clinical Research|
|Madison, Wisconsin, United States, 53704|
|Study Director:||Medical Director||Astellas Pharma Global Development|