A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers

Study Overview
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Brief Summary
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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).

Official Title
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A Single-center, Randomized, Double-blind, Two-period Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RO5285119
* Drug: RO5285119 placebo
* Drug: risperidone
* Drug: risperidone placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female adults, 18 - 50 years of age inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis Body mass index (BMI) 18 to 30 kg/m2 inclusive Women have to be postmenopausal or surgically sterile Male subjects must use a barrier method of contraception for the duration of the study and for 3 months after last dosing 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 Hypersensitivity to risperidone or any of its excipients Any other known contraindications to risperidone as stated in the SmPC

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo + risperidone<br> | Drug: RO5285119 placebo<br>* multiple doses<br>Drug: risperidone<br>* single dose<br>|
| Placebo Comparator: Placebo +placebo<br> | Drug: RO5285119 placebo<br>* multiple doses<br>Drug: risperidone placebo<br>* single dose<br>|
| Active Comparator: RO5285119 + placebo<br> | Drug: RO5285119<br>* multiple doses<br>Drug: risperidone placebo<br>* single dose<br>|
| Experimental: RO5285119 + risperidone<br> | Drug: RO5285119<br>* multiple doses<br>Drug: risperidone<br>* single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |