Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

Sponsor

Corcept Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT03259542

Collaborator

(none)

Enrollment

Location

Arm

4.1

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Interaction Potentiation Healthy	Drug: Mifepristone 300 MG Drug: Itraconazole 100 MG	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Aug 9, 2017

Actual Primary Completion Date :

Dec 11, 2017

Actual Study Completion Date :

Dec 11, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]
Elimination half-life (T1/2)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SeaView Research	Miami	Florida	United States	33126

Sponsors and Collaborators

Corcept Therapeutics

Investigators

Study Director: Ada Lee, MD, Corcept Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Corcept Therapeutics

ClinicalTrials.gov Identifier:

NCT03259542

Other Study ID Numbers:

C1073-38

First Posted:

Aug 23, 2017

Last Update Posted:

Feb 22, 2018

Last Verified:

Oct 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Itraconazole

Mifepristone

Study Results

No Results Posted as of Feb 22, 2018