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CompletedNCT01483469Updated Nov 2, 2016

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

A Phase 1 interventional study of RO4917523 and RO5011232 in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    Concept Proof

    Drug: RO5011232

  • Experimental
    Receptor Occupancy

    Drug: RO4917523 · Drug: RO5011232

Interventions

  • DrugRO4917523

    orally daily, 14 days

  • DrugRO5011232

    \[11C\]-RO5011232 intravenously

06

What researchers measure

Primary outcomes

  1. Part I: mGlu5 receptor binding of [11C]-RO5011232 radiotracer in human brain, assessed by positron emission tomography (PET)

    Time frame: approximately 6 months

  2. Part II: Dosimetry/radiation safety of [11C]-RO5011232 assessments by whole body PET scan

    Time frame: approximately 6 months

  3. Part III: Measurement of test-retest precision of PET images of regions of interest in the human brain

    Time frame: approximately 6 months

  4. Part IV: Correlation between RO4917523 plasma concentration and R04917523 binding to mGlu5 receptor in brain

    Time frame: approximately 6 months

Secondary outcomes

  1. Safety of [11C]-RO5011232 administered intravenously at microdose level: Incidence of adverse events

    Time frame: approximately 6 months

  2. Part IV: In vitro binding potential (reference region with no specific binding of radiotracer) assessed by PET

    Time frame: approximately 6 months

  3. Part IV: Safety of 14-day treatment with RO4917523: Incidence of adverse events

    Time frame: approximately 6 months

07

Study locations

2 sites
  • Baltimore, Maryland 21224, United States
  • Baltimore, Maryland 21225, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01483469
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Dec 1, 2011
Start date
Dec 2011
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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