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Completed

NCT Number: NCT01483469

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 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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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO4917523

Drug

orally daily, 14 days

RO5011232

Drug

[11C]-RO5011232 intravenously

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 1, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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