The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of atorvastatin.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
24
oral
oral
Clinical Pharmacology of Miami
Miami, Florida, United States
Pharmacokinetic (PK) profile for atorvastatin (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 12 at predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose
PK profile for atorvaststin (in plasma): t1/2, tmax, CL/F, and Vz/F
Apparent terminal elimination half-life (t1/2), time to attain Cmax (tmax), apparent body clearance after oral dosing (CL/F), and apparent volume of distribution (Vz/F)
Time frame: Days 1 and 12 at predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose
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 11 and 12 at predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 20 hours post dose
PK Isavuconazole (in plasma): trough concentration (Ctrough)
Time frame: Predose on Day 10 and Days 13 through 14 and on Day 15 predose and 24 hours post dose
Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs
Time frame: Day 1 through Day 24 (± 2 days)
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