Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00752843 | A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy Volunteers | PHASE1 | COMPLETED | 20 | — | — | Sep 1, 2008 | Nov 1, 2008 | Feb 17, 2012 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| mifepristone + fluvastatin | DRUG | Subjects will receive a single oral dose of 40 mg PO of fluvastatin on three occasions: alone (Day 1), at the same time as a single dose of CORLUX 1200 mg (Day 8) and during concomitant administration of CORLUX 1200 mg/day (CORLUX on Days 8-14, fluvastatin on Day 14). |
Inclusion Criteria: * Male or female healthy volunteers * Body mass index (BMI) of 18-32 kg/m2 * Female subjects must have a negative serum pregnancy test result prior to entry into the study * All female subjects must not be of child-bearing potential * All male subjects with female partners of ch...