Schizophrenia Clinical Trial
Official title:
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
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).
Status | Completed |
Enrollment | 9 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 25 Years to 50 Years |
Eligibility |
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 |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacodynamics: Brain PDE10 occupancy by RO5545965 | up to Day 2 | No | |
Primary | PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations | up to Day 2 | No | |
Secondary | Safety: Incidence of adverse events | up to 12 days | No | |
Secondary | Pharmacokinetics: Plasma concentrations of RO5545965 | up to Day 5 | No |
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