Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

NCT03259542 | Completed Phase 1 FDA Drug

• 1 other identifier: C1073-38
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Cmax of mifepristone at Day 42 compared to Day 28

  Maximum (peak) plasma drug concentration (Cmax)

  Day 42 compared to Day 28

• AUC0-24 of mifepristone at Day 42 compared to Day 28

  Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)

  Day 42 compared to Day 28

Secondary Outcomes (4)

• Cmax of mifepristone at Day 42 compared to Day 14

  Day 42 compared to Day 14

• AUC0-24 of mifepristone compared to Day 14

  Day 42 compared to Day 14

• T1/2 of mifepristone

  Days 14 and 28

• Ctrough of mifepristone

  Days 1 through 28

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Drug: Mifepristone 300 MG; Drug: Itraconazole 100 MG

Interventions

Mifepristone 300 MG 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

Arm 1

Itraconazole 100 MG DRUG

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

Arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Not based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

SeaView Research

Miami, Florida, 33126, United States

Location

MeSH Terms

Interventions

Mifepristone; Itraconazole

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Ada Lee, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 23, 2017
• Study Start: August 9, 2017
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: February 22, 2018

Record last verified: 2017-10

Locations

US (1)