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Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

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ClinicalTrials.gov Identifier: NCT03259542
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : February 22, 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 daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations are given after a meal.

Condition or disease Intervention/treatment Phase
Drug Interaction Potentiation Healthy Drug: Mifepristone 300 MG Drug: Itraconazole 100 MG Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Open-Label, Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inhibitor (Itraconazole) of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : December 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Arm 1
Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered.
Drug: Mifepristone 300 MG
mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days

Drug: Itraconazole 100 MG
itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing




Primary Outcome Measures :
  1. Cmax of mifepristone at Day 42 compared to Day 28 [ Time Frame: Day 42 compared to Day 28 ]
    Maximum (peak) plasma drug concentration (Cmax)

  2. AUC0-24 of mifepristone at Day 42 compared to Day 28 [ Time Frame: Day 42 compared to Day 28 ]
    Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)


Secondary Outcome Measures :
  1. Cmax of mifepristone at Day 42 compared to Day 14 [ Time Frame: Day 42 compared to Day 14 ]
  2. AUC0-24 of mifepristone compared to Day 14 [ Time Frame: Day 42 compared to Day 14 ]
  3. T1/2 of mifepristone [ Time Frame: Days 14 and 28 ]
    Elimination half-life (T1/2)

  4. Ctrough of mifepristone [ Time Frame: Days 1 through 28 ]
    Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) (Ctrough)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Not based on self-representation of gender identity
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

Exclusion Criteria:

  • Have multiple drug allergies, or be allergic to any of the components of mifepristone or itraconazole
  • Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
  • In the 1 year before study drug administration, have a history of drug or alcohol abuse
  • In the 6 calendar months before study drug administration, on average

    • Have smoked more than 5 cigarettes/day
    • Have consumed more than 21 units of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)
  • In 2 months prior to study drug administration, have donated/lost blood or plasma in excess of 400 mL
  • In the 30 days before 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): NCT03259542


Locations
United States, Florida
SeaView Research
Miami, Florida, United States, 33126
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Ada Lee, MD Corcept Therapeutics

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT03259542     History of Changes
Other Study ID Numbers: C1073-38
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Itraconazole
Hydroxyitraconazole
Mifepristone
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Luteolytic Agents
Menstruation-Inducing Agents