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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Mifepristone 300 MG, 1 tablet |
|
| Cohort 2 | Experimental | Mifepristone 1500 MG, 5 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3 | Maximum (peak) plasma drug concentration (Cmax) | 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) | 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) | 18 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of mifepristone metabolites of period 1 vs Cmax of mifepristone metabolites of period 3 | 18 days | |
| AUC0-tz of mifepristone metabolites of period 1 vs AUC0-tz of mifepristone metabolites of period 3 | 18 days |
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Inclusion Criteria:
Exclusion Criteria:
Have multiple drug allergies, or be allergic to any of the components of mifepristone or rifampin
Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
Have a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia or endometrial carcinoma
Breastfeeding
In the 1 year before first study drug administration, have a history of drug or alcohol abuse
In the 6 calendar months before first study drug administration, on average
In the 2 calendar months before first study drug administration, have donated/lost blood or plasma in excess of 400 mL
In the 30 days before first study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine
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| Name | Affiliation | Role |
|---|---|---|
| Ada Lee, MD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SeaView Reserch | Miami | Florida | 33126 | United States |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3 | 18 days |
| D011083 |
| Polycyclic Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |