A Study of RO5285119 in Healthy Volunteers

Study Overview
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Brief Summary
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This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each subject.

Official Title
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A Single- and Multiple Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study in Two Single-Center Study Parts to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5285119 Following Oral Administration in Healthy Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RO5285119
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male adults, 18 to 45 years of age (Part 1) or healthy male or female adults, 18 to 65 years of age (Part 2) Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive Female subjects must be surgically sterile or postmenopausal Male subjects must use a barrier method of contraception for the duration of the study and for the three months after the last dosing Exclusion Criteria: History or presence of any significant disease or disorder Positive for hepatitis B. hepatitis C or HIV infection History of drug or alcohol abuse or suspicion of regular consumption of drugs of abuse Participation in an investigational drug or device study within 3 months prior to first dosing Donation of blood within 3 months prior to first dosing Regular smoker (>5 cigarettes, >3 pipe-fulls, >3 cigars per day) History of hypersensitivity or allergic reactions Part 2: Contraindications for MRI scans

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: Active<br> | Drug: RO5285119<br>* single and multiple ascending oral doses<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* single and multiple oral doses<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 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration - time curve (AUC) |  | up to 5 weeks | 
| Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS |  | up to 5 weeks | 
| Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin) |  | up to 5 weeks | 
| Pharmacodynamics: Functional Magnetic Resonance Imaging |  | up to 5 weeks | 
| Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b) |  | up to 5 weeks |