Drug Interaction Potentiation, Healthy
Conditions
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.
Interventions
DRUGMifepristone 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
DRUGItraconazole 100 MG
itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing
Sponsors
Corcept Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of mifepristone at Day 42 compared to Day 28 | Day 42 compared to Day 28 | Maximum (peak) plasma drug concentration (Cmax) |
| AUC0-24 of mifepristone at Day 42 compared to Day 28 | Day 42 compared to Day 28 | Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of mifepristone at Day 42 compared to Day 14 | Day 42 compared to Day 14 | — |
| AUC0-24 of mifepristone compared to Day 14 | Day 42 compared to Day 14 | — |
| T1/2 of mifepristone | Days 14 and 28 | Elimination half-life (T1/2) |
| Ctrough of mifepristone | 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) |
Countries
United States
Outcome results
None listed