Drug Interaction Study of Isavuconazole and Tacrolimus
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of tacrolimus after single dose administration.
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|