Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

• Status: Completed
• Trial end date: 2017-12-11
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Hydroxyitraconazole; Itraconazole; Mifepristone

Criteria

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