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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00979368 | Safety Study of BMS-816336 in Healthy Male Subjects | PHASE1 | COMPLETED | 40 | — | — | Nov 1, 2009 | Feb 1, 2010 | Feb 23, 2011 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| BMS-816336 or placebo (Panel 1) | ACTIVE_COMPARATOR | - |
| BMS-816336 or placebo (Panel 2) | ACTIVE_COMPARATOR | - |
| BMS-816336 or placebo (Panel 3) | ACTIVE_COMPARATOR | - |
| BMS-816336 or placebo (Panel 4) | ACTIVE_COMPARATOR | - |
| BMS-816336 or placebo (Panel 5) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BMS-816336 | DRUG | Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days |
| Placebo | DRUG | Suspension, Oral, 0 mg, Once on Day 1 only, 4 days |
Inclusion Criteria: * Healthy male subjects * BMI of 18 to 32 kg/m² * Men only, ages 18-55 years Exclusion Criteria: * Sexually active men not using effective birth control if their partners are WOCBP * Any significant acute or chronic medical illness * Family history of Gilbert's disease * Histo...