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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002256-14 | EudraCT Number |
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This open-label, fixed-sequence, two-period study will assess the effect of multiple dose valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4917838 | Drug | Multiple doses |
| |
| valproate |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of valproate multiple-dose administration on pharmacokinetics of RO4917838 at steady-state: Area under the concentration-time curve (AUC) | Period 2, day 10 and day 15 | |
| Effect of RO4917838 multiple-dose administration on the pharmacokinetics of valproate at steady state: Area under the concentration-time curve (AUC) | Period 1, day 5 and Period 2, Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 16 days |
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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 |
|---|---|---|---|---|---|---|
| Rueil-Malmaison | 92502 | France |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Drug |
Multiple doses |
|
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |