Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:2/24/2018
Start Date:August 9, 2017
End Date:December 11, 2017

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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

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.


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
We found this trial at
1
site
Miami, Florida 33126
Phone: 306-644-9903
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mi
from
Miami, FL
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