Drug Interaction Study of Isavuconazole and Tacrolimus
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Tacrolimus
|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 Tacrolimus: A Phase 1, Open Label, Sequential Study in Healthy Adult Subjects|
- Composite of Pharmacokinetic (PK) variables for tacrolimus (in whole blood) : AUClast , AUCinf, Cmax, tmax , Vz /F, CL/F and t1/2 [ Time Frame: Days 1 and 20 ] [ Designated as safety issue: No ]Area under the curve (AUC) from time of dosing to last quantifiable concentration (AUClast ), AUC from time 0 extrapolated to infinity (AUCinf), and maximum concentration (Cmax), 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 (t1/2 ).
- PK variable for isavuconazole (in plasma): trough concentration (Ctrough) [ Time Frame: Days 18 and Days 22 through 29 ] [ Designated as safety issue: No ]
- Composite of PK variable for isavuconazole (in plasma): trough concentration (Ctrough), AUC during the time interval between consecutive dosing (AUCtau), maximum concentration (Cmax),and time to attain Cmax (tmax) [ Time Frame: Days 19 and 20 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Experimental: isavuconazole and tacrolimus||
Other Names:Drug: tacrolimus
Subjects will receive a single dose of tacrolimus on Day 1 followed by a 15 day wash-out period (time from tacrolimus dosing to isavuconazole dosing).
On Days 16 and 17, isavuconazole will be dosed three times daily (TID). TID doses will be administered 8 hours apart. On Days 18 through 28 isavuconazole will be administered once daily (QD). All subjects will be administered a single dose of tacrolimus on Day 20. A follow up visit will occur approximately 7 days after the last dose of isavuconazole. Blood samples for pharmacokinetics will be collected throughout the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535547
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53704|
|Study Director:||Medical Director||Astellas Pharma Global Development|