A PET Study With RO5545965 in Healthy Male Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: RO5545965

Study type: Interventional

Funder types: Industry

Identifiers

NCT01923025

BP28844

2013-000538-36 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: Male

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

9 participants in 1 patient group

RO5545965

Experimental group

Treatment:

Drug: RO5545965