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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000772-42 | EudraCT Number |
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This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a cross-over design. The anticipated time on study treatment is 40 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Period 1 | Experimental |
| |
| Dosing Period 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluvoxamine | Drug | Multiple doses of fluvoxamine |
| |
| RO4917523 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration time curve | Period 1: Pre-dose and up to Day 14, Period 2: pre-dose and up to Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of adverse events | 9 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 |
|---|---|
| D016666 | Fluvoxamine |
| C000596770 | 2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine |
| ID | Term |
|---|---|
| D010091 | Oximes |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Drug |
Single dose of RO4917523 |
|