A PET Study With RO5545965 in Healthy Male Volunteers

Study Overview
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Brief Summary
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This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission tomography (PET).

Official Title
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A Single Centre, Open Label Study to Characterize the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 After a Single Dose in Healthy Male Volunteers Using [11C]IMA107 Positron Emission Tomography

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: RO5545965


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects, 25 to 50 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 with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method (i.e. condom), for the duration of the study and for 30 days after the last dose Exclusion Criteria: History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, haematological or allergic disease, metabolic disorder, cancer or cirrhosis History of clinically significant hypersensitivity or allergic drug reactions Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day) Positive for hepatitis B, hepatitis C, or HIV infection Evidence of significant cardiovascular disease or disorder Participation in an investigational drug or device study within 3 months prior to first administration of the study drug or within 6 times the elimination half-life, whichever is longer Previous inclusion in a research and/or medical protocol or any clinical procedures involving nuclear medicine, PET, occupational exposure to ionizing radiation or radiological investigations with significant exposure to radiation, excluding dental X-ray and common X-rays of chest or extremities Subject has any condition that would prevent an MRI from accurately or safely being performed [eg, claustrophobia, cardiac pacemaker, metallic implants or clips] Subject unable to lie on his back in the PET or MRI scanner for a period of 90 minutes Contraindication for arterial cannulation Unsuitable veins for repeated venipuncture

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RO5545965<br> | Drug: RO5545965<br>* Single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: Brain PDE10 occupancy by RO5545965 |  | up to Day 2 | 
| PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations |  | up to Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | up to 12 days | 
| Pharmacokinetics: Plasma concentrations of RO5545965 |  | up to Day 5 |