Status:
COMPLETED
Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
Lead Sponsor:
Corcept Therapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 mifeprist...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03258372
Start Date
August 16 2017
End Date
November 29 2017
Last Update
February 23 2018
Active Locations (1)
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1
SeaView Reserch
Miami, Florida, United States, 33126