Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Mifepristone

• Registration Number: NCT03258372
• Lead Sponsor: Corcept Therapeutics

Brief Summary

This is a Phase 1, single center, fixed sequence, open label, drug-drug interaction study of the effect of multiple doses of rifampin 600 mg daily, a strong CYP3A inducer, on the exposure of mifepristone at 2 dose levels.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-16
• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-23
• Status Verified: 2017-11
• Primary Completion: 2017-11-29
• Study Completion: 2017-11-29
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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
• Female subjects of childbearing potential must use highly effective contraception with low user-dependency. The only acceptable method is an intrauterine device (IUD), provided that the subject has tolerated its use for at least 3 months before the first dose of study drug and undertakes not to have it removed for 1 month after the last dose of study drug. Use of hormonal contraception (by any route, including intrauterine hormone releasing systems) or hormone replacement therapy is NOT acceptable.

Exclusion Criteria

• Have multiple drug allergies, or be allergic to any of the components of mifepristone or rifampin

• Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)

• Have a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia or endometrial carcinoma

• Breastfeeding

• In the 1 year before first study drug administration, have a history of drug or alcohol abuse

• In the 6 calendar months before first study drug administration, on average

  • Have smoked more than 5 cigarettes/day
  • Have consumed more than 21 units of alcohol/week for male subjects or 14 units for female subjects (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)

• In the 2 calendar months before first study drug administration, have donated/lost blood or plasma in excess of 400 mL

• In the 30 days before first study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	Mifepristone	Mifepristone 300 MG, 1 tablet
Cohort 2	Mifepristone	Mifepristone 1500 MG, 5 tablets

Primary Outcome Measures

Name	Time	Method
Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3	18 days	Maximum (peak) plasma drug concentration (Cmax)
AUCinf of mifepristone of period 1 vs AUCinf of mifepristone of period 3	18 days	Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
AUC0-tz of mifepristone of period 1 vs AUC0-tz of mifepristone of period 3	18 days	Area under the concentration-time curve from zero up to the last concentration above the lower limit of quantification of the assay (AUC0-tz)

Secondary Outcome Measures

Name	Time	Method
Cmax of mifepristone metabolites of period 1 vs Cmax of mifepristone metabolites of period 3	18 days
AUC0-tz of mifepristone metabolites of period 1 vs AUC0-tz of mifepristone metabolites of period 3	18 days
AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3	18 days

Trial Locations

Locations (1)

SeaView Reserch; 🇺🇸 Miami, Florida, United States