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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483469
First received: November 29, 2011
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This open label, non-randomized, parallel group study will evaluate [11C]-RO5011 232 as radiotracer for brain mGlu5 receptor occupancy and investigate the bindin g of RO49917523 to human mGlu5 brain receptor at steady-state in healthy volunte ers. In Parts I, II and III, positron emission tomography (PET) assessments of s pecific uptake of the radiotracer and whole body dosimetry will be made after in travenous injection of [11C]-RO5011232. In Part IV, subjects will receive RO4917 523 orally daily for 14 days while receiving three single intravenous bolus inje ctions of [11C]-RO5011232. The anticipated time on study treatment is up to 4 we eks.


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 ]

Enrollment: 56
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483469

Locations
United States, Maryland
Baltimore, Maryland, United States, 21225
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: November 3, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 24, 2014