A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers

Study Overview
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Brief Summary
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This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and alcohol, and placebo to RO4917838 and non-alcoholic drink.

Official Title
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A Single Center, Randomized, Double-blind, Single-dose, Four Period, Crossover Study to Investigate Pharmacodynamics and Pharmacokinetics of RO4917838 Alone or With Concomitant Administration of Alcohol in Healthy Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RO4917838
* Drug: Placebo to RO4917838
* Other: Alcohol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult healthy volunteers, 18 to 45 years, inclusive Body Mass Index (BMI) 18 to 30 kg/m2, inclusive Non-smoker or smoker of fewer than 10 cigarettes per day Females, who are not menopausal must agree to use two adequate methods of contraception Exclusion Criteria: Any current medical condition or disease that would render the volunteer unsuitable for the study, or would place the volunteer at undue risk History of alcoholism History of drug abuse and/or addiction within one year of study start History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RO4917838 + non-alcoholic drink<br> | Drug: RO4917838<br>* Single dose of RO4917838<br>|
| Experimental: RO4917838 + alcohol<br> | Drug: RO4917838<br>* Single dose of RO4917838<br>Other: Alcohol<br>* Standard alcoholic drink<br>|
| Placebo Comparator: RO4917838 placebo + alcohol<br> | Drug: Placebo to RO4917838<br>* Single dose of placebo to RO4917838<br>Other: Alcohol<br>* Standard alcoholic drink<br>|
| Placebo Comparator: RO4917838 placebo + non-alcoholic drink<br> | Drug: Placebo to RO4917838<br>* Single dose of placebo to RO4917838<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838 |  | Day 1 of each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of alcohol on pharmacokinetics (Area under the concentration time curve) of RO4917838 |  | Days 1, 2, 3, 4, 6, and 8 of each treatment period | 
| Safety: Incidence of adverse events |  | Approximately 4 months |