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

NCT ID: NCT03258372

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-16
• Study Completion Date: 2017-11-29

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cohort 1

Mifepristone 300 MG, 1 tablet

Group Type: EXPERIMENTAL

Mifepristone

Intervention Type: DRUG

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

Cohort 2

Mifepristone 1500 MG, 5 tablets

Group Type: EXPERIMENTAL

Mifepristone

Intervention Type: DRUG

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

Interventions

Mifepristone

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

Intervention Type: DRUG

Other Intervention Names

rifampin

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Corcept Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ada Lee, MD

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

SeaView Reserch

Miami, Florida, United States

Countries

United States

Other Identifiers

C1073-37

Identifier Type: -

Identifier Source: org_study_id