The primary purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of methadone after single dose administration. The secondary purpose is to assess the safety and tolerability of isavuconazole alone and in combination with methadone.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
24
oral
oral
Parexel International, LLC
Glendale, California, United States
Composite of pharmacokinetics (PK) of plasma for R-methadone and S-methadone: AUClast, AUCinf, and Cmax
Area under the curve (AUC) from time of dosing to last quantifiable concentration (AUClast ), AUC from time 0 extrapolated to infinity (AUCinf), maximum concentration (Cmax)
Time frame: Days 1 and 20
Composite of pharmacokinetics (PK) of plasma for R-methadone and S-methadone : tmax,t1/2, Vz/F, and CL/F
Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2), apparent volume of distribution (Vz /F), and apparent body clearance after oral dosing (CL/F)
Time frame: Days 1 and 20
PK of plasma isavuconazole: trough concentration (Ctrough)
Time frame: Days 18 and Days 21 through 29
Composite of PK of plasma isavuconazole: AUC during the time interval between consecutive dosing (AUCtau), Cmax, and tmax
Time frame: Days 19 and 20
Safety assessed by recording of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs
Time frame: Up to Day 36
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