Skip to main content
OpenTrials
Completed

NCT Number: NCT03259542

Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SeaView Research

Miami, Florida, 33126, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Itraconazole 100 MG

Drug

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

Primary outcomes

  1. Cmax of mifepristone at Day 42 compared to Day 28

    Time frame: Day 42 compared to Day 28

    Maximum (peak) plasma drug concentration (Cmax)

  2. AUC0-24 of mifepristone at Day 42 compared to Day 28

    Time frame: Day 42 compared to Day 28

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

Secondary outcomes

  1. Cmax of mifepristone at Day 42 compared to Day 14

    Time frame: Day 42 compared to Day 14

  2. AUC0-24 of mifepristone compared to Day 14

    Time frame: Day 42 compared to Day 14

  3. T1/2 of mifepristone

    Time frame: Days 14 and 28

    Elimination half-life (T1/2)

  4. Ctrough of mifepristone

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2017
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.