A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Single Center, Randomized, Double-blind, Parallel-design Study to Investigate the Safety and Tolerability of RO4995819 in Combination With Citalopram Following Oral Administration in Healthy Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RO4995819
* Drug: citalopram
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult healthy male or female subjects, 18 to 65 years of age inclusive (healthy status defined as absence of evidence of any active or chronic disease) Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive Female subjects who are not either surgically sterile or post-menopausal must commit to using a barrier form of contraception in addition to either an intrauterine device or hormonal contraception until at least 5 months after the last dose of study drug Male subjects must use a barrier method of contraception throughout the study and for up to 5 months after the last dose of study drug (applies also to surgically sterilized males) Willing not to participate in any other clinical trial with an investigational drug for at least 5 months following the last dose of study drug Exclusion Criteria: Pregnant or lactating females Suspicion of regular consumption of drug of abuse or positive test for alcohol on Day -2 Hepatitis B, hepatitis C or HIV infection Smokers of >5 cigarettes or equivalent tobacco intake per day Any confirmed allergic reaction against any drug, or multiple allergies (non-active hay fever is acceptable) Participation in an investigational drug or device study within 3 months prior to dosing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RO4995819<br>* multiple oral doses, Days 10-16<br>Drug: citalopram<br>* multiple oral doses, Days 1-16<br>|
| Placebo Comparator: 2<br> | Drug: citalopram<br>* multiple oral doses, Days 1-16<br>Drug: placebo<br>* multiple oral doses, Days 10-16<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | up to 58 days | 

Secondary Outcome Measures

| Outcome Measure | 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 |