Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor
Completed · Phase 1
Conditions studied: Drug Interaction Potentiation, Healthy
In brief
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.
Key facts
- Study ID
- NCT03259542
- Run by
- Corcept Therapeutics
- People needed
- 33
- Starts
- 2017-08-09
- Expected to finish
- 2017-12-11
- Last updated by the study team
- 2018-02-22
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.
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
You may not qualify if…
- 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
Where it is running
- SeaView Research — Miami, Florida, United States
Full record on ClinicalTrials.gov
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