This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations are given after a meal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
33
mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days
itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing
SeaView Research
Miami, Florida, United States
Cmax of mifepristone at Day 42 compared to Day 28
Maximum (peak) plasma drug concentration (Cmax)
Time frame: Day 42 compared to Day 28
AUC0-24 of mifepristone at Day 42 compared to Day 28
Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)
Time frame: Day 42 compared to Day 28
Cmax of mifepristone at Day 42 compared to Day 14
Time frame: Day 42 compared to Day 14
AUC0-24 of mifepristone compared to Day 14
Time frame: Day 42 compared to Day 14
T1/2 of mifepristone
Elimination half-life (T1/2)
Time frame: Days 14 and 28
Ctrough of mifepristone
Trough plasma concentration (measured concentration at the end of a dosing interval at steady state \[taken directly before next administration\]) (Ctrough)
Time frame: Days 1 through 28
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