The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
24
oral
contraceptive pill consisting of ethinyl estradiol and norethindrone
Clinical Pharmacology of Miami
Miami, Florida, United States
Pharmacokinetic (PK) variables for ethinyl estradiol and norethindrone (in plasma): AUCinf , AUClast, and Cmax
AUC from time 0 extrapolated to infinity (AUCinf), Area under the curve (AUC) from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)
Time frame: For Days 1 and 13: predose and 12 times post dose; for Days 2, 3, 4, 5, 14, 15, 16, and 17: one time each day
PK variable for ethinyl estradiol and norethindrone (in plasma): 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), apparent body clearance after oral dosing (CL/F)
Time frame: For Days 1 and 13: pre-dose and 12 times post dose; for Days 2, 3, 4, 5, 14, 15, 16, and 17: one time each day
PK variable for isavuconazole (in plasma): Ctrough
trough concentration (Ctrough)
Time frame: For Day 11: predose; for Days 12 and 13: predose and 12 times post dose; for Day 14 and 15: predose; and for Day 16: predose and 24 hours post dose
PK variable for isavuconazole (in plasma): AUCtau, Cmax, and tmax
Area under the concentration-time curve during the time interval between consecutive dosing (AUCtau)
Time frame: For Days 12 and 13: predose and 12 times post dose
Safety assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs)
Time frame: Day 1 through Day 24 ± 2 days
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