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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003232-76 | EudraCT Number |
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This single-center, open-label, one-sequence, 2-period, within-subject study in 2 cohorts will evaluate the effects of multiple doses of itraconazole and fluoxetine on the pharmacokinetics of a single dose of RO5285119 in healthy volunteers. In Cohort 1, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, itraconazole on Days 1-8 of Period 2 with coadministration of RO5285119 on Day 4. In Cohort 2, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, fluoxetine on Days 1-12 of Period 2 with coadministration of RO5285119 on Day 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Itraconazole DDI) | Experimental |
| |
| Cohort 2 (Fluoxetine DDI) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5285119 | Drug | Single dose, alone and after repeated administration of itraconazole or fluoxetine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of multiple doses of itraconazole and fluoxetine on the pharmacokinetics of a single dose of RO5285119 in healthy volunteers: Maximum concentration (Cmax) / Area under the concentration-time curve (AUC) | up to 5 and 7 days post-dose for cohort 1 and cohort 2, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of a single dose of RO5285119 administered in combination with itraconazole (cohort 1) and fluoxetine (cohort 2): Incidence of adverse events | up to 6 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 |
|---|---|---|---|---|---|---|
| Zuidlaren | 9471 GP | Netherlands |
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| fluoxetine | Drug | Multiple doses |
|
| itraconazole | Drug | Multiple doses |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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