The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of prednisolone after single dose administration of prednisone. This study will also assess the safety and tolerability of isavuconazole alone and in combination with prednisone.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
21
oral
oral
Parexel International, LLC
Glendale, California, United States
Pharmacokinetics of plasma prednisolone: AUClast,
Area under the concentration-time curve (AUC) from the time of dosing to the last quantifiable concentration (AUC last)
Time frame: Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose
Pharmacokinetics of plasma prednisolone: AUCinf
AUC from the time of dosing to infinity (AUCinf),
Time frame: Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose
Pharmacokinetics of plasma prednisolone: Cmax
Maximum concentration (Cmax)
Time frame: Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose
Pharmacokinetics of plasma isavuconazole concentration: Trough concentration (Ctrough)
Time frame: Day 7 predose; Day10 predose and Day 11 postdose
Composite of pharmacokinetics of plasma isavuconazole concentration: AUCtau, Cmax, and tmax
AUC during the time interval between consecutive dosing (AUCtau), Cmax, and time to attain Cmax (tmax)
Time frame: Day 8 predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose; Day 9 predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours postdose
Composite of pharmacokinetics of plasma prednisone: AUClast, AUCinf, Cmax, 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: Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Composite of pharmacokinetics of plasma prednisolone: t max and t1/2
Time frame: Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose
Safety assessed by recording of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs
Time frame: 18 days