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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258372
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Mifepristone Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 16, 2017
Actual Primary Completion Date : November 29, 2017
Actual Study Completion Date : November 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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 Name: 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 Name: rifampin




Primary Outcome Measures :
  1. Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3 [ Time Frame: 18 days ]
    Maximum (peak) plasma drug concentration (Cmax)

  2. AUC0-tz of mifepristone of period 1 vs AUC0-tz of mifepristone of period 3 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 18 days ]
  2. AUC0-tz of mifepristone metabolites of period 1 vs AUC0-tz of mifepristone metabolites of period 3 [ Time Frame: 18 days ]
  3. AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3 [ Time Frame: 18 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258372


Locations
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United States, Florida
SeaView Reserch
Miami, Florida, United States, 33126
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Ada Lee, MD Corcept Therapeutics
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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT03258372    
Other Study ID Numbers: C1073-37
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rifampin
Mifepristone
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents