A PET Study With RO5545965 in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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