Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites

Corcept Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Mifepristone

Study type

Interventional

Funder types

Industry

Identifiers

NCT03258372

C1073-37

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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