The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration. Safety and tolerability of isavuconazole will be assessed alone and in combination with MMF.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
24
oral
oral
Parexel International, LLC
Glendale, California, United States
Composite of pharmacokinetic (PK) variables of plasma mycophenolic acid (MPA) and phenolic glucuronide of MPA (MPAG): AUClast, AUCinf, Cmax
Area under the concentration-time curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast), AUC from the time of dosing to infinity (AUCinf), and maximum concentration (Cmax)
Time frame: Days 1 and 13: predose, and at 0.5, .75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose
PK of plasma isavuconazole: Trough concentration (Ctrough)
Time frame: Day 11, Days 14-16, predose and on Day 17, predose and 24 hours postdose
Composite of PK variables of plasma isavuconazole concentration: AUCtau, Cmax, and tmax
AUC during the time interval between consecutive dosing (AUCtau), time to attain Cmax (tmax)
Time frame: Days 12 and 13: predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, and 24 hours postdose
Composite of PK variables of plasma MPA: tmax, t1/2, Vz/F, and CL/F
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 13: 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
Composite of PK variables of plasma MPAG: tmax and t1/2
Time frame: Days 1 and 13: predose, and at 0.5, .75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose
Safety assessed through the reporting of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs
Time frame: Through Day 17
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