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

Healthy Clinical Trial

Official title:

A Phase 1, Open-Label, Fixed-Sequence, Crossover Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inducer of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258372
• Other study ID #: C1073-37
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2017
• Last updated: February 21, 2018
• Start date: August 16, 2017
• Est. completion date: November 29, 2017

Study information

• Verified date: November 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 doses of rifampin 600 mg daily, a strong CYP3A inducer, on the exposure of mifepristone at 2 dose levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• 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

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Mifepristone
Period 1: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2; then Period 2: rifampin 300 MG (2 capsules) for a total of 600 MG daily for 14 days for both cohorts; then Period 3: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2

Locations

Country	Name	City	State
United States	SeaView Reserch	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 of period 1 vs Cmax of mifepristone of period 3	Maximum (peak) plasma drug concentration (Cmax)	18 days
Primary	AUC0-tz of mifepristone of period 1 vs AUC0-tz of mifepristone of period 3	Area under the concentration-time curve from zero up to the last concentration above the lower limit of quantification of the assay (AUC0-tz)	18 days
Primary	AUCinf of mifepristone of period 1 vs AUCinf of mifepristone of period 3	Area under the plasma concentration-time curve from time zero to infinity (AUCinf)	18 days
Secondary	Cmax of mifepristone metabolites of period 1 vs Cmax of mifepristone metabolites of period 3		18 days
Secondary	AUC0-tz of mifepristone metabolites of period 1 vs AUC0-tz of mifepristone metabolites of period 3		18 days
Secondary	AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3		18 days