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
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483469
First received: November 29, 2011
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
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 receptor at steady-state in healthy volunteers. In Parts I, II and III, positron emission tomography (PET) assessments of specific uptake of the radiotracer and whole body dosimetry will be made after intravenous injection of [11C]-RO5011232. In Part IV, subjects will receive RO4917523 orally daily for 14 days while receiving three single intravenous bolus injections of [11C]-RO5011232. The anticipated time on study treatment is up to 4 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteer |
Drug: RO4917523 Drug: RO5011232 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official 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. |
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Part I: mGlu5 receptor binding of [11C]-RO5011232 radiotracer in human brain, assessed by positron emission tomography (PET) [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
- Part II: Dosimetry/radiation safety of [11C]-RO5011232 assessments by whole body PET scan [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
- Part III: Measurement of test-retest precision of PET images of regions of interest in the human brain [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
- Part IV: Correlation between RO4917523 plasma concentration and R04917523 binding to mGlu5 receptor in brain [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety of [11C]-RO5011232 administered intravenously at microdose level: Incidence of adverse events [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
- Part IV: In vitro binding potential (reference region with no specific binding of radiotracer) assessed by PET [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
- Part IV: Safety of 14-day treatment with RO4917523: Incidence of adverse events [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Concept Proof |
Drug: RO5011232
[11C]-RO5011232 intravenously
|
| Experimental: Receptor Occupancy |
Drug: RO4917523
orally daily, 14 days
Drug: RO5011232
[11C]-RO5011232 intravenously
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483469
Contacts
| Contact: Please reference Study ID Number: BP27890 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, Maryland | |
| Recruiting | |
| Baltimore, Maryland, United States, 21225 | |
| Recruiting | |
| Baltimore, Maryland, United States, 21224 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01483469 History of Changes |
| Other Study ID Numbers: | BP27890 |
| Study First Received: | November 29, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 19, 2013