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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00547560 | Study Evaluating Multiple Doses Of GSI-953 Within The Elderly Population | PHASE1 | COMPLETED | 49 | — | — | Aug 1, 2007 | Oct 1, 2009 | Apr 4, 2011 | 1 | United States |
| NCT00441987 | Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953 | PHASE1 | COMPLETED | 96 | — | — | Feb 1, 2007 | Jul 1, 2009 | May 3, 2022 | 1 | Japan |
Safety
| Arm | Type | Description |
|---|---|---|
| GSI+Placebo | OTHER | - |
| Single Dose of GSI-953 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSI-953 | DRUG | Oral capsule, 10- and 50-mg, either once a day for 14 days or twice a day for 14 days, depending on cohort assignment. |
Inclusion Criteria: * Men or women, greater than or equal to 65 years of age. * Women of nonchildbearing potential (WONCP) may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with FSH greater than or equal t...