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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00909766 | Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects | PHASE1 | COMPLETED | 113 | — | — | Aug 1, 2009 | Jun 1, 2011 | Nov 4, 2015 | 1 | United States |
| NCT00878020 | Safety Study to Evaluate BMS-830216 in Healthy Subjects | PHASE1 | COMPLETED | 48 | — | — | May 1, 2009 | Sep 1, 2009 | Feb 23, 2011 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Panel A | ACTIVE_COMPARATOR | - |
| Panel B | ACTIVE_COMPARATOR | - |
| Panel C | ACTIVE_COMPARATOR | - |
| Panel D | ACTIVE_COMPARATOR | - |
| Panel E | ACTIVE_COMPARATOR | - |
| Panel F | ACTIVE_COMPARATOR | Low Dose |
| Panel G | ACTIVE_COMPARATOR | High Dose |
| Panel H | PLACEBO_COMPARATOR | - |
| Arm 1 | ACTIVE_COMPARATOR | BMS-830216 (10 mg) |
| Arm 2 | ACTIVE_COMPARATOR | BMS-830216 (30 mg) |
| Arm 3 | ACTIVE_COMPARATOR | BMS-830216 (100 mg) |
| Arm 4 | ACTIVE_COMPARATOR | BMS-830216 (300 mg) |
| Arm 5 | ACTIVE_COMPARATOR | BMS-830216 (600 mg) |
| Arm 6 | ACTIVE_COMPARATOR | BMS-830216 (1200 mg) |
| Name | Type | Description |
|---|---|---|
| BMS-830216 | DRUG | Capsules, Oral, 30 mg, once daily, 28 days |
| Placebo | DRUG | Capsules, Oral, 0 mg, once daily, 28 days |
Inclusion Criteria: * Obese subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Body Mass Index (BMI) of 30 to 40 kg/m², inclusive * Women who are not of childbearing potential (ie, who ar...