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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01051700 | A Safety Study in Healthy Volunteers to Evaluate Safety, How Fast the Drug is Absorbed, and the Side Effects of the Drug in Humans | PHASE1 | COMPLETED | 72 | — | — | Jan 12, 2010 | May 27, 2010 | Nov 14, 2017 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| 5 mg | EXPERIMENTAL | GW786034 |
| 10 mg | EXPERIMENTAL | GW786034 |
| 20 mg | EXPERIMENTAL | GW786034 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| GW786034 | DRUG | Investigational product |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, based on a medical evaluation in...