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This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and alcohol, and placebo to RO4917838 and non-alcoholic drink.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO4917838 + non-alcoholic drink | Active Comparator |
| |
| RO4917838 + alcohol | Experimental |
| |
| RO4917838 placebo + alcohol | Placebo Comparator |
| |
| RO4917838 placebo + non-alcoholic drink | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4917838 | Drug | Single dose of RO4917838 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838 | Day 1 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of alcohol on pharmacokinetics (Area under the concentration time curve) of RO4917838 | Days 1, 2, 3, 4, 6, and 8 of each treatment period | |
| Safety: Incidence of adverse events | Approximately 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIOTRIAL | Rennes | 35042 | France |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo to RO4917838 | Drug | Single dose of placebo to RO4917838 |
|
| Alcohol | Other | Standard alcoholic drink |
|