A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive either RO5545965 or matching placebo daily for 12 days.

Official Title
-----------------
A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Multiple Ascending-Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 Following Oral Administration in Healthy Subjects.

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: RO5545965
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male and female volunteers, 18 - 64 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination Body mass index (BMI) 18 to 30 kg/m2 inclusive Female subject must be post-menopausal or surgically sterile Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for at least 30 days after the last dose of study drug Exclusion Criteria: History of any clinically significant disease or disorder Concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study Clinically significant abnormalities in laboratory test results Suspicion of regular consumption of drug of abuse Positive for hepatitis B, hepatitis C or HIV infection Participation in an investigational drug or device study within 90 days prior to screening Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day) History of clinically significant hypersensitivity or allergic drug reactions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>* Multiple ascending doses<br>|
| Experimental: RO5545965<br> | Drug: RO5545965<br>* Multiple ascending doses<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration-time curve (AUC) |  | 17 days | 
| Pharmacokinetics: Plasma concentrations |  | 17 days | 
| Pharmacokinetics: Urine concentrations |  | 13 days | 
| Pharmacodynamics: Serum prolactin levels |  | Day 12 | 
| Pharmacodynamics: Glucose tolerance test |  | Day 11 | 
| Pharmacodynamics: Probabilistic learning tasks |  | Days 6, 8 and 10 |