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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

NCT ID: NCT01483469

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Concept Proof

Group Type ACTIVE_COMPARATOR

RO5011232

Intervention Type DRUG

\[11C\]-RO5011232 intravenously

Receptor Occupancy

Group Type EXPERIMENTAL

RO4917523

Intervention Type DRUG

orally daily, 14 days

RO5011232

Intervention Type DRUG

\[11C\]-RO5011232 intravenously

Interventions

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RO4917523

orally daily, 14 days

Intervention Type DRUG

RO5011232

\[11C\]-RO5011232 intravenously

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Baltimore, Maryland, United States

Site Status

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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BP27890

Identifier Type: -

Identifier Source: org_study_id