The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of digoxin in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
24
oral
oral
Parexel International
Baltimore, Maryland, United States
Pharmacokinetic (PK) profile for digoxin (in plasma):AUCinf, AUClast, Cmax
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), and maximum concentration(Cmax)
Time frame: Days 1 and 19
PK profile for digoxin (in plasma): tmax, Vz/F, CL/F, and t1/2
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)
Time frame: Days 1 and 19
PK Isavuconazole (in plasma): trough concentration (Ctrough)
Time frame: Day 17 and Days 21 through 27
PK profile for Isavuconazole (in plasma): AUCtau, Cmax, and tmax
AUC during time interval between consecutive dosing (AUCtau), maximum concentration (Cmax),and time to attain Cmax (tmax)
Time frame: Days 18 and 19
Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs.
Time frame: Day 1 through Day 34 (± 2 days)
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