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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000916-24 | EudraCT Number |
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This open-label, two period crossover study will evaluate the effect of multiple doses of activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period 2, only a single dose of RO4995819 but no activated charcoal will be administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4995819 | Drug | single oral dose |
| |
| activated charcoal |
| Measure | Description | Time Frame |
|---|---|---|
| C max: maximum observed plasma concentration | 18 weeks | |
| T max: time of maximum observed plasma concentration | 18 weeks | |
| T1/2: apparent terminal half-life | 18 weeks | |
| AUC: area under the plasma concentration-time curve | 18 weeks |
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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 |
|---|---|---|---|---|---|---|
| Rennes | 35042 | France |
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| ID | Term |
|---|---|
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| Drug |
orally 3 times daily, Days 1-7 |
|