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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00966966 | Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered | PHASE1 | COMPLETED | 17 | — | — | Sep 1, 2009 | Dec 1, 2009 | Aug 20, 2010 | 1 | Netherlands |
| NCT00519298 | Study Evaluating Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects | PHASE1 | COMPLETED | 25 | — | — | Oct 1, 2007 | Mar 1, 2008 | Apr 22, 2008 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | SAM-531\_gemfibrozil |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SAM-531 and gemfibrozil | DRUG | 2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days |
| SAM-531 | DRUG | dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531 |
| placebo | OTHER | placebo |
| Donepezil | DRUG | dosage form: 5 mg encapsulated tablets one single dose of 5 mg. |
Inclusion Criteria: * Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg. * Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG rea...