Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

Phase 1

Completed

• Conditions: Drug Interaction Potentiation; Healthy
• Interventions: Drug: Mifepristone 300 MG; Drug: Itraconazole 100 MG

• Registration Number: NCT03259542
• Lead Sponsor: Corcept Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-07
• Study Start: 2017-08-09
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-23
• Status Verified: 2017-10
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Itraconazole 100 MG	Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered.
Arm 1	Mifepristone 300 MG	Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered.

Primary Outcome Measures

Name	Time	Method
Cmax of mifepristone at Day 42 compared to Day 28	Day 42 compared to Day 28	Maximum (peak) plasma drug concentration (Cmax)
AUC0-24 of mifepristone at Day 42 compared to Day 28	Day 42 compared to Day 28	Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)

Secondary Outcome Measures

Name	Time	Method
Cmax of mifepristone at Day 42 compared to Day 14	Day 42 compared to Day 14
Ctrough of mifepristone	Days 1 through 28	Trough plasma concentration (measured concentration at the end of a dosing interval at steady state \[taken directly before next administration\]) (Ctrough)
AUC0-24 of mifepristone compared to Day 14	Day 42 compared to Day 14
T1/2 of mifepristone	Days 14 and 28	Elimination half-life (T1/2)

Trial Locations

Locations (1)

SeaView Research; 🇺🇸 Miami, Florida, United States