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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003231-31 | EudraCT Number |
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This single-center, randomized, double-blind, two-period crossover study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects will be randomized to one of 4 treatment sequences of two periods to receive multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout period of approximately 3 weeks between treatment periods. Anticipated time on study is up to 12 weeks (from screening through study completion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + risperidone | Placebo Comparator |
| |
| Placebo +placebo | Placebo Comparator |
| |
| RO5285119 + placebo | Active Comparator |
| |
| RO5285119 + risperidone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5285119 | Drug | multiple doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax) | Pre-dose to 24 hours post-dose | |
| Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC) | Pre-dose to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 12 weeks | |
| Pharmacodynamic markers for risperidone: Prolactin levels | Pre-dose to 6 hours post-dose | |
| Pharmacodynamic assessments for risperidone: Level of sedation |
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Inclusion Criteria:
Exclusion Criteria:
Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse
Positive for hepatitis B, hepatitis C or HIV infection
History of clinically significant hypersensitivity or allergic reactions
Disorders of the central nervous system, including psychiatric disorders, behavioural disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson
Regular smoker (>5 cigarettes, >3 pipe-fulls, >3 cigars per day)
Administration of an investigational drug or device within 3 months prior to first dosing
Any other known contraindications to risperidone as stated in the SmPC
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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 |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| RO5285119 placebo |
| Drug |
multiple doses |
|
| risperidone | Drug | single dose |
|
| risperidone placebo | Drug | single dose |
|
| Pre-dose to 24 hours post-dose |
| Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax) | Day 1 to Day 18 |
| Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC) | Day1 to Day 18 |