A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

Study Overview
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Brief Summary
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This double-blind, randomized, placebo-controlled, 2-Part study will evaluate the pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian volunteers. In Part 1, healthy Japanese volunteers will be randomized to receive 2 oral doses of either RO4917523 or placebo, with a washout period of 21 days between dosing. In Part 2, healthy Japanese and Caucasian volunteers will be randomized in cohorts to receive either RO4917523 or placebo orally daily for 14 days.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics, Safety and Tolerability of RO4917523 Conducted in 2 Phases: a Single-Dose, Cross-Over Administration to Healthy Japanese Subjects and a Multiple-Dose Administration to Healthy Japanese and Caucasian Subjects.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RO4917523
* Drug: RO4917523
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese (Part 1 + 2) or Caucasian (Part 2) adults, 18- 50 years of age Japanese subjects must have Japanese parents and grandparents who were born in Japan Caucasian subjects must have 4 Caucasian grandparents Body mass index (BMI) 18.5 to 26 kg/m2, and a body weight of at least 45 kg Non-smoker for at least 90 days prior to dosing Day 1 Exclusion Criteria: Participation in a clinical trial with an investigational drug within 90 days prior to dosing Day 1. (Volunteers having participated in Part 1 will not be allowed to participate in Part 2 and vice versa) History or evidence of any clinically significant disease or disorder Pregnant or lactating women Positive for hepatitis B, hepatitis C or HIV Positive drug screen test, positive cotinine test and/or positive alcohol test Any confirmed significant allergic reactions to any drug, or multiple allergies in the judgement of the investigator

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br> | Drug: RO4917523<br>* single oral doses<br>Drug: placebo<br>* oral doses<br>|
| Experimental: Part 2<br> | Drug: RO4917523<br>* multiple oral doses<br>Drug: placebo<br>* oral doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Pharmacokinetics: Area under the concentration - time curve (AUC) (single/multiple oral dose in healthy Japanese subjects) |  | approximately 12 weeks | 
| Part 2: Comparison of pharmacokinetics (area under the concentration - time curve [AUC]) between healthy Caucasian and Japanese subjects after 14 days of daily oral dosing |  | approximately 9 weeks | 
| Safety: Incidence of adverse events in Japanese an Caucasian subjects |  | approximately 21 weeks |