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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00499629 | Study Evaluating the Safety of FXR-450 in Healthy Subjects | PHASE1 | COMPLETED | 64 | — | — | Oct 1, 2007 | Feb 1, 2008 | Mar 13, 2008 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Arm 1: FXR 450 |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| FXR 450 | DRUG | capsule, single oral doses from 10 mg to 450 mg |
| placebo | DRUG | capsule similar to active drug |
Inclusion Criteria: * Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening. * Healthy as determined by the investigator on the basis of screening evaluations. * Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to...