NCT03259542

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug Interaction Potentiation
• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-08-09
• Primary completion: 2017-12-11
• Completion: 2017-12-11
• First posted: 2017-08-23
• Last updated: 2018-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study