Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

A Phase 1, Open-Label, Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inhibitor (Itraconazole) of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Drug Interaction Potentiation
• Intervention / Treatment: Drug: Mifepristone 300 MG; Drug: Itraconazole 100 MG

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • SeaView Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered.	Drug: 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; Drug: Itraconazole 100 MG; itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Elimination half-life (T1/2)	Days 14 and 28
Ctrough of mifepristone	Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) (Ctrough)	Days 1 through 28

Collaborators and Investigators

• Sponsor: Corcept Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2017
• Primary Completion (Actual): December 11, 2017
• Study Completion (Actual): December 11, 2017

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; 14-alpha Demethylase Inhibitors; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone; Itraconazole
• Other Study ID Numbers: C1073-38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No