The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of bupropion.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
24
oral
oral
Clinical Pharmacology of Miami
Miami, Florida, United States
Pharmacokinetic (PK) profile for bupropion (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: Day 1 at pre-dose and 0.5,1,1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 48, 72,and 96 hours post-dose and Day 15 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,10,12,16, 20, 24, 48, 72, 96,120, and 144 hours post-dose
PK profile for bupropion (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: Day 1 at pre-dose and 0.5,1,1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 48, 72,and 96 hours post-dose and Day 15 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,10,12,16, 20, 24, 48, 72, 96,120, and 144 hours post-dose
PK profile for hydroxybupropion (in plasma): AUCinf, AUClast, Cmax, t1/2, tmax
Time frame: Day 1 at pre-dose and 0.5,1,1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 48, 72,and 96 hours post-dose and Day 15 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,10,12,16, 20, 24, 48, 72, 96,120, and 144 hours post-dose
PK profile for Isavuconazole (in plasma): AUCtau, Cmax, and tmax
AUC during time interval between consecutive dosing (AUCtau)
Time frame: Days 14 and 15 at pre-dose and 0.5,1,1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 20 hours post-dose
PK Isavuconazole (in plasma): trough concentration (Ctrough)
Time frame: Pre-dose on Days 10 through 13 and Days 16 through 19 and on Day 20: predose and 24 hours post-dose
Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs
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Time frame: Days 1 through 27 (± 2 days)