Healthy
Conditions
Brief summary
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.
Interventions
DRUGMifepristone
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
Sponsors
Corcept Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Be healthy * Have a BMI of 18 to 32 kg/m2, inclusive, and body weight more than 50 kg (110 pounds) * Be judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings * Have suitable veins for multiple venipuncture/cannulation * Female subjects of childbearing potential must use highly effective contraception with low user-dependency. The only acceptable method is an intrauterine device (IUD), provided that the subject has tolerated its use for at least 3 months before the first dose of study drug and undertakes not to have it removed for 1 month after the last dose of study drug. Use of hormonal contraception (by any route, including intrauterine hormone releasing systems) or hormone replacement therapy is NOT acceptable.
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 * Have smoked more than 5 cigarettes/day * Have consumed more than 21 units of alcohol/week for male subjects or 14 units for female subjects (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3 | 18 days | Maximum (peak) plasma drug concentration (Cmax) |
| AUC0-tz of mifepristone of period 1 vs AUC0-tz of mifepristone of period 3 | 18 days | Area under the concentration-time curve from zero up to the last concentration above the lower limit of quantification of the assay (AUC0-tz) |
| AUCinf of mifepristone of period 1 vs AUCinf of mifepristone of period 3 | 18 days | Area under the plasma concentration-time curve from time zero to infinity (AUCinf) |
Secondary
| Measure | 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 |
| AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3 | 18 days |
Countries
United States
Outcome results
None listed