This is a Phase 1, single center, fixed sequence, open label, drug-drug interaction study of the effect of multiple doses of rifampin 600 mg daily, a strong CYP3A inducer, on the exposure of mifepristone at 2 dose levels.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
Period 1: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2; then Period 2: rifampin 300 MG (2 capsules) for a total of 600 MG daily for 14 days for both cohorts; then Period 3: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2
SeaView Reserch
Miami, Florida, United States
Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3
Maximum (peak) plasma drug concentration (Cmax)
Time frame: 18 days
AUC0-tz of mifepristone of period 1 vs AUC0-tz of mifepristone of period 3
Area under the concentration-time curve from zero up to the last concentration above the lower limit of quantification of the assay (AUC0-tz)
Time frame: 18 days
AUCinf of mifepristone of period 1 vs AUCinf of mifepristone of period 3
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: 18 days
Cmax of mifepristone metabolites of period 1 vs Cmax of mifepristone metabolites of period 3
Time frame: 18 days
AUC0-tz of mifepristone metabolites of period 1 vs AUC0-tz of mifepristone metabolites of period 3
Time frame: 18 days
AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3
Time frame: 18 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.