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This randomized, double-blind, parallel-arm study will assess the safety and tolerability of RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4995819 | Drug | multiple oral doses, Days 10-16 |
| |
| citalopram |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | up to 58 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram | 17 days | |
| Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram | up to 58 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 |
|---|---|---|---|---|---|---|
| Strasbourg | 67064 | France |
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| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Drug |
multiple oral doses, Days 1-16 |
|
| placebo | Drug | multiple oral doses, Days 10-16 |
|
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |