Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

NCT ID: NCT03259542

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-09
• Study Completion Date: 2017-12-11

Brief 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.

Conditions

Drug Interaction Potentiation; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm 1

Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered.

Group Type: EXPERIMENTAL

Mifepristone 300 MG

Intervention Type: DRUG

mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days

Itraconazole 100 MG

Intervention Type: DRUG

itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing

Interventions

Mifepristone 300 MG

mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days

Intervention Type: DRUG

Itraconazole 100 MG

itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• 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 Research

Miami, Florida, United States

Countries

United States

Other Identifiers

C1073-38

Identifier Type: -

Identifier Source: org_study_id