A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers

Study Overview
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Brief Summary
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This randomized, double-blind, placebo-controlled, parallel group study will evaluate the pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers. Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or placebo. In-unit period is 6 days.

Official Title
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A Single-Center, Randomized, Investigator/Subject-Blind, Single Dose, Placebo-Controlled, Parallel Group Study to Investigate the Pharmacodynamic and Pharmacokinetic Behavior of RO5508887 in Plasma and Cerebral Spinal Fluid Following Oral Administration in Healthy Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Placebo
* Drug: RO5508887


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects, 18 to 65 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination Body mass index (BMI) 18 to 30 kg/m2 inclusive Must agree to use a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study drug Donation of blood over 500 mL within 6 weeks before drug administration Exclusion Criteria: Concomitant disease or condition or treatment that could interfere with the conduct of the study or would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study Allergy to lidocaine Suspicion of regular consumption of drug of abuse Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day) Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection Participation in an investigational drug or device study (last administration of study drug or installation of device) within 6 weeks before RO5508887 administration and within 5 mean half-lives of receiving previous investigational drug before RO5508887 administration. In addition, subject cannot participate unless completely recovered from previous invasive or study procedure Donation of blood over 500 mL within 6 weeks before drug administration

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

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single oral dose<br>|
| Experimental: RO5508887<br> | Drug: RO5508887<br>* Single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of amyloid biomarkers |  | Pre-dose and up to fullow up, 8-12 days post dose | 
| Cerebral spinal fluid levels of amyloid biomarkers |  | Pre-dose and up to 30 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 6 months | 
| Pharmacokinetics: Plasma and cerebral spinal fluid concentrations of RO5508887 (and metabolites) |  | Pre-dose and up to 72 hours post-dose |