Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259542
• Other study ID #: C1073-38
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2017
• Last updated: February 21, 2018
• Start date: August 9, 2017
• Est. completion date: December 11, 2017

Study information

• Verified date: October 2017
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 11, 2017
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Interaction Potentiation
• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	SeaView Research	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of mifepristone at Day 42 compared to Day 28	Maximum (peak) plasma drug concentration (Cmax)	Day 42 compared to Day 28
Primary	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	Cmax of mifepristone at Day 42 compared to Day 14		Day 42 compared to Day 14
Secondary	AUC0-24 of mifepristone compared to Day 14		Day 42 compared to Day 14
Secondary	T1/2 of mifepristone	Elimination half-life (T1/2)	Days 14 and 28
Secondary	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