Clinical trial NCT03258372: Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-08-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3
timeFrame: 18 days
measure: AUC0-tz of mifepristone of period 1 vs AUC0-tz of mifepristone of period 3
timeFrame: 18 days
measure: AUCinf of mifepristone of period 1 vs AUCinf of mifepristone of period 3
timeFrame: 18 days
Secondary outcomes:
measure: Cmax of mifepristone metabolites of period 1 vs Cmax of mifepristone metabolites of period 3
timeFrame: 18 days
measure: AUC0-tz of mifepristone metabolites of period 1 vs AUC0-tz of mifepristone metabolites of period 3
timeFrame: 18 days
measure: AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3
timeFrame: 18 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: SeaView Reserch
state: Florida
Study officials:
affiliation: Corcept Therapeutics
name: Ada Lee, MD
role: STUDY_DIRECTOR
References: