A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Single Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: bitopertin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Bitopertin<br> | Drug: bitopertin<br>* Single oral dose<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration-time curve |  | Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose | 
| Pharmacokinetics: Urine concentrations drug/metabolites |  | Pre-dose and up to 72 hours post-dose |