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The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tasimelteon | Experimental | single dose |
|
| Placebo | Placebo Comparator | single dose |
|
| Active Control | Active Comparator | single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasimelteon | Drug | oral capsule |
| |
| Active Control Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP) | Day 1 of Treatment Period 1, Treatment Period 2, and Treatment Period 3 (each Period is 1 day, separated by washout) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Laval | Quebec | Canada |
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| ID | Term |
|---|---|
| C478745 | tasimelteon |
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| Drug |
oral capsule |
|
| Tasimelteon Placebo | Drug | oral capsule |
|
| Active Control | Drug | oral capsule |
|