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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00718731 | Study GSI-136 in Healthy Young and Healthy Elderly Subjects | PHASE1 | COMPLETED | 80 | — | — | Mar 1, 2008 | Aug 1, 2008 | Apr 2, 2010 | 1 | United States |
| NCT00719394 | Study Evaluating Safety of GSI 136 in Young and Elderly Japanese Males | PHASE1 | COMPLETED | 72 | — | — | Mar 1, 2008 | Aug 1, 2008 | Jul 10, 2009 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Subject on active drug |
| 2 | PLACEBO_COMPARATOR | Subject on placebo |
| GSI 136 | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GSI-136 | DRUG | - |
| Placebo | OTHER | - |
| GSI 136 | DRUG | - |
\<Inclusion: 1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years or greater than 65 years, inclusive, at screening. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than 1 year (with follicle-stimulat...