Schizophrenia
Conditions
Brief summary
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).
Interventions
DRUGRO5545965
Single dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | up to 12 days |
| Pharmacokinetics: Plasma concentrations of RO5545965 | up to Day 5 |
Countries
United Kingdom
Outcome results
None listed