A Human Proof of Concept Study for [11C]-RO5011232 as Radiotracer and Study of the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-State in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2013
• Main ID: NCT01483469
• Date of registration: 29/11/2011
• Primary sponsor: Hoffmann-La Roche
• Public title: A Human Proof of Concept Study for [11C]-RO5011232 as Radiotracer and Study of the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-State in Healthy Volunteers
• Scientific title: Human Proof of Concept Positron Emission Tomography Study to Investigate [11C]-RO5011232 as a Radiotracer for Brain mGlu5 Receptor Occupancy and to Investigate the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-state.
• Date of first enrolment: December 2011
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01483469
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Countries of recruitment

United States

Contacts

• Name: Please reference Study ID Number: BP27890 www.roche.com/about_roche/roche_worldwide.htm

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male and female volunteers as determined by medical history, physical
examination, 12-lead ECG, and routine clinical laboratory measurements

- Age 18 to 65 years inclusive

- Body mass index (BMI) between 18 to30 kg/m2 inclusive and body weight at least 50 kg

- Appropriate body size (less than 195 cm [6 feet and 5 inches]) in order to
accommodate the whole body scanning

Exclusion Criteria:

- History of or presence of clinically significant psychiatric condition, as evaluated
by a psychiatrist before enrolment

- History of head trauma with prolonged loss of consciousness (>10 minutes) or any
neurological condition or a history of migraine headaches

- Contraindications to MRI procedures (Part I, III and IV)

- Subjects suffering from claustrophobia or who would be unable to undergo magnetic
resonance imaging (MRI) or PET scanning

- Positive pregnancy test at screening or on any day preceding a PET scan

- Lactating women

- Positive for hepatitis B, hepatitis C or HIV infection

- Any history of alcohol or drug abuse within the last 6 months

- Regular smoker or nicotine user (>10 cigarettes per day)

- Participation in an investigational drug or device study within three months prior to
screening



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteer

Intervention(s)

Drug: RO4917523

Drug: RO5011232

Primary Outcome(s)

Part I: mGlu5 receptor binding of [11C]-RO5011232 radiotracer in human brain, assessed by positron emission tomography (PET) [Time Frame: approximately 6 months]

Part II: Dosimetry/radiation safety of [11C]-RO5011232 assessments by whole body PET scan [Time Frame: approximately 6 months]

Part III: Measurement of test-retest precision of PET images of regions of interest in the human brain [Time Frame: approximately 6 months]

Part IV: Correlation between RO4917523 plasma concentration and R04917523 binding to mGlu5 receptor in brain [Time Frame: approximately 6 months]

Secondary Outcome(s)

Part IV: In vitro binding potential (reference region with no specific binding of radiotracer) assessed by PET [Time Frame: approximately 6 months]

Part IV: Safety of 14-day treatment with RO4917523: Incidence of adverse events [Time Frame: approximately 6 months]

Safety of [11C]-RO5011232 administered intravenously at microdose level: Incidence of adverse events [Time Frame: approximately 6 months]

Secondary ID(s)

BP27890

Source(s) of Monetary Support

Please refer to primary and secondary sponsors