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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00480467 | Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese Males | PHASE1 | COMPLETED | 32 | — | — | Sep 1, 2006 | Aug 1, 2007 | Dec 5, 2007 | 1 | Japan |
| NCT00479440 | Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 in Healthy Adults | PHASE1 | COMPLETED | 56 | — | — | Aug 1, 2006 | Mar 1, 2007 | Dec 5, 2007 | - | — |
| Name | Type | Description |
|---|---|---|
| SAM-315 | DRUG | - |
Inclusion criteria: * Men aged 20 to 45 years (inclusive) at the time of getting informed consent. * Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (BMI = \[weight (kg)\]/\[height (m)\]2). * Healthy as determined by the investigator on the basis of medical history, p...