Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

Corcept Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Drug Interaction Potentiation

Treatments

Drug: Mifepristone 300 MG

Drug: Itraconazole 100 MG

Study type

Interventional

Funder types

Industry

Identifiers

NCT03259542

C1073-38

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 daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations are given after a meal.

Enrollment

33 patients

Sex

Male

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

Exclusion criteria

Have multiple drug allergies, or be allergic to any of the components of mifepristone or itraconazole
Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
In the 1 year before study drug administration, have a history of drug or alcohol abuse
In the 6 calendar months before study drug administration, on average
- Have smoked more than 5 cigarettes/day
- Have consumed more than 21 units of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)
In 2 months prior to study drug administration, have donated/lost blood or plasma in excess of 400 mL
In the 30 days before study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine