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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001195-11 | EudraCT Number |
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This single-center, open-label, parallel group study will evaluate the effects of multiple doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours) from Day 1 to Day 17.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO4602522 | Active Comparator |
| |
| RO4602522 + ketoconazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4602522 | Drug | Single oral dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of multiple doses of ketoconazole on RO4602522 single dose pharmacokinetics: Area under the concentration-time curve (AUC) | Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 3 months | |
| RO4602522 metabolites: Plasma/urine concentrations | Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22 |
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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 |
|---|---|---|---|---|---|---|
| Zuidlaren | 9471 GP | Netherlands |
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| ID | Term |
|---|---|
| C000614721 | sembragiline |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| ketoconazole |
| Drug |
Multiple oral doses |
|