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

NCT03258372 | Completed Phase 1 FDA Drug

• 1 other identifier: C1073-37
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3

  Maximum (peak) plasma drug concentration (Cmax)

  18 days

• 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

• 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 Outcomes (3)

• 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

Study Arms (2)

Cohort 1

EXPERIMENTAL

Mifepristone 300 MG, 1 tablet

Drug: Mifepristone

Cohort 2

EXPERIMENTAL

Mifepristone 1500 MG, 5 tablets

Drug: Mifepristone

Interventions

Mifepristone DRUG

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

Also known as: rifampin

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

SeaView Reserch

Miami, Florida, 33126, United States

Location

MeSH Terms

Interventions

Mifepristone; Rifampin

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds

Study Officials

• Ada Lee, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: August 16, 2017
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: February 23, 2018

Record last verified: 2017-11

Locations

US (1)