Drug Interaction Study of Isavuconazole and Cyclosporine
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of cyclosporine in healthy adult subjects.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Cyclosporine: A Phase 1, Open-Label, Sequential Study in Healthy Adult Subjects|
- Composite of Pharmacokinetic (PK) variables for cyclosporine (in whole blood): Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to the last quantifiable concentration (AUClast), Cmax [ Time Frame: Days 1 and 15 ] [ Designated as safety issue: No ]
- Composite of PK variables for cyclosporine (in whole blood): time to attain Cmax(tmax), apparent volume of distribution (Vz/F), apparent body clearance after oral dosing (CL/F), and apparent terminal elimination half-life (t 1/2) [ Time Frame: Days 1 and 15 ] [ Designated as safety issue: No ]
- PK variable for Isavuconazole (in plasma): trough concentration (Ctrough) [ Time Frame: Day 13 and Days 17 through 19 ] [ Designated as safety issue: No ]
- Composite of PK variables for Isavuconazole (in plasma): AUC during time interval between consecutive dosing (AUCtau), maximum concentration (Cmax),and time to attain Cmax (tmax) [ Time Frame: Days 14 and 15 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Isavuconazole and cyclosporine
Isavuconazole three times per day (TID) for two days followed by once a day (QD) for 6 days. Cyclosporine single doses on Days 1 and 15.
Other Name: BAL8557Drug: cyclosporine
Other Name: Neoral
Subjects will be enrolled to receive a single dose of cyclosporine on Day 1 followed by a 10-day wash-out period (time from cyclosporine dosing to isavuconazole dosing). On Days 11 and 12, isavuconazole will be dosed three times daily (TID). On Days 13 through 18, isavuconazole will be administered once daily (QD). All subjects will be administered a single dose of cyclosporine on Day 15. Subjects will be confined in the study center from Day -1 until Day 5 and from Day 10 until Day 19.
A follow up visit will be scheduled approximately 7 ± 2 days after final dosing of isavuconazole.
Blood and urine samples will be taken at various times during the study.
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53704|
|Study Director:||Medical Director||Astellas Pharma Global Development|