Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This open label, non-randomized, parallel group study will evaluate \[11C\]-RO5011232 as radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to human mGlu5 brain r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01483469
Start Date
December 1 2011
End Date
October 1 2013
Last Update
November 2 2016
Active Locations (2)
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1
Baltimore, Maryland, United States, 21224
2
Baltimore, Maryland, United States, 21225