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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00948662 | Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects | PHASE1 | COMPLETED | 124 | — | — | Sep 1, 2009 | Dec 1, 2010 | Feb 25, 2013 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | active arm/healthy young |
| 2 | PLACEBO_COMPARATOR | placebo arm |
| 3 | OTHER | ketoconazole interaction evaluation |
| Name | Type | Description |
|---|---|---|
| SAM-760 | DRUG | SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day |
| Placebo of SAM-760 | DRUG | SAM-760 matching placebo capsule, single dose, 1 day, |
| ketoconazole | DRUG | Ketoconazole oral tablets, 200 mg bid, 14 days |
Inclusion Criteria: * Men or women of non-childbearing potential aged 18 to 50 years inclusive (healthy young subjects) and \> 65 years (healthy elderly subjects) at screening. * Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight \>= 50 kg. Exclusion Criteria: * Presence or hist...