A Study of Bitopertin (RO4917838) in Healthy Male Volunteers
A Study of Bitopertin (RO4917838) in Healthy Male Volunteers
This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the
 safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male
 volunteers. Subjects will be randomized in cohorts to receive single oral doses of either
 bitopertin or placebo.
Inclusion Criteria:

 -  Male healthy volunteer, 18 to 60 years of age inclusive

 -  Body mass index (BMI) 19-35 kg/m2 inclusive

 -  Supine blood pressure within the normal range of the center and heart rate >/= 40
 provided QTcB is <450 ms

 -  Subjects must agree to use a barrier method of contraception (e.g. condom) for the
 duration of the study and for 30 days after study completion

 Exclusion Criteria:

 -  History or evidence of any clinically significant disease or disorder

 -  Clinically significant ECG abnormalities

 -  Positive for hepatitis B, hepatitis C or HIV infection

 -  Previous treatment with iron for iron deficiency anemia

 -  Regular smoker (>10 cigarettes, >3 pipefuls or >3 cigars per day)

 -  History of alcohol and/or drug abuse or addiction within the last 2 years before study
 start

 -  Any confirmed significant allergic reactions against any drug, or multiple allergies
 in the judgment of the investigator

 -  Participation in a clinical study with an investigational drug within the last three
 months prior to screening

 -  Any condition or disease detected during the medical interview/physical examination
 that would render the subject unsuitable for the study, place the subject at undue
 risk or interfere with the ability of the subject to complete the study in the opinion
 of the investigators or their designee