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

• Sponsor: Corcept Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03258372
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 13.9

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Mifepristone	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Aug 16, 2017
• Actual Primary Completion Date: Nov 29, 2017
• Actual Study Completion Date: Nov 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Mifepristone 300 MG, 1 tablet	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; Other Names: rifampin
Experimental: Cohort 2 Mifepristone 1500 MG, 5 tablets	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; Other Names: rifampin

Outcome Measures

Primary Outcome Measures

1. Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3 [18 days]

   Maximum (peak) plasma drug concentration (Cmax)

2. 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)

3. 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)

Secondary Outcome Measures

1. Cmax of mifepristone metabolites of period 1 vs Cmax of mifepristone metabolites of period 3 [18 days]

2. AUC0-tz of mifepristone metabolites of period 1 vs AUC0-tz of mifepristone metabolites of period 3 [18 days]

3. AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3 [18 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SeaView Reserch	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: NCT03258372
• Other Study ID Numbers: C1073-37
• First Posted: Aug 23, 2017
• Last Update Posted: Feb 23, 2018
• Last Verified: Nov 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rifampin; Mifepristone

Study Results

No Results Posted as of Feb 23, 2018