A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers

Study Overview
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Brief Summary
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This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.

Official Title
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A Single-Center, Randomized, Double-Blind, Single and Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food) and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Placebo
* Drug: RO5508887
* Drug: RO5508887


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers, 18-45 (Part 1) or 18-65 (Part 2) years of age inclusive; healthy status is defined by absence of evidence of any active or chronic disease Body Mass Index (BMI) 18 to 30 kg/m2 inclusive Male subjects must use a barrier method of contraception for the duration of the study and for 30 days after the last dose Exclusion Criteria: Suspicion of regular consumption of drugs of abuse Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day) Positive for hepatitis B, hepatitis C or HIV infection History of hypersensitivity or severe drug reaction Participation in an investigational drug or device study within three months before the first 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1a<br> | Drug: RO5508887<br>* Single ascending doses<br>|
| Placebo Comparator: Part 1b<br> | Drug: Placebo<br>* Single ascending doses<br>|
| Experimental: Part 2<br> | Drug: RO5508887<br>* Single doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability: Incidence of adverse events |  | up to approximately 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Plasma concentrations of RO5508887 |  | predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose | 
| Pharmacodynamics: Urine levels of RO5508887 |  | predose to 72 hours post-dose | 
| Pharmacodynamics: Plasma levels of markers of amyloid deposition (Abeta1-40/Abeta1-42) |  | predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose | 
| Effect of food on pharmacokinetics (plasma concentrations) of a single dose of RO5508887 |  | predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 36, 48, 60, 72 hours post-dose |