NCT01420952

Brief Summary

Background: \- (11C)mGlu1 is a new drug that helps to show where a protein, mGluR1, is found in the brain. The drug contains a small amount of radioactivity that can be detected by imaging studies like positron emission tomography (PET) scans. By looking at the mGluR1 receptors, researchers hope to better understand how they are involved in general health, brain disorders, and addiction. Objectives:

  • To test how (11C)mGlu1 is distributed in the brain and body.
  • To measure how mGluR1 receptors display (11C)mGlu1 during imaging studies. Eligibility: \- Healthy volunteers between 18 and 50 years of age. Design:
  • Participants will be screened with a medical history, physical exam, and blood and urine tests. This study requires four visits to the NIH Clinical Center.
  • Participants will have an initial evaluation, a magnetic resonance imaging (MRI) scan, a PET scan, and a final blood sample after the PET scan, all at different visits.
  • The MRI and PET scans will focus on the brain. Participants will receive (11C)mGlu1, and have scans to see how it shows up in the brain.
  • Some participants will have whole body imaging studies to see how (11C)mGlu1 shows up in the body.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2012

Completed
Last Updated

December 16, 2019

Status Verified

November 27, 2012

Enrollment Period

1.3 years

First QC Date

August 19, 2011

Last Update Submit

December 13, 2019

Conditions

DosimetryPharmacokinetics

Keywords

Positron Emission Tomograhy (PET)Metabolic Glutamate ReceptorsBrain

Interventions

[11C]LY2428703DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers subjects aged 18 50 with medical history/physical exam, electrocardiogram (ECG), and laboratory tests within normal limits within 60 days of the PET scan.

You may not qualify if:

  • \<TAB\>Lifetime psychiatric illness or severe systemic disease based on history and physical exam.
  • \<TAB\>Serious medical illness likely to modify brain anatomy and/or physiology (seizure disorders, past brain surgery, etc.)
  • \<TAB\>High blood pressure, as demonstrated by at least two resting measurements above 140/100, separated by at least 30 min.
  • \<TAB\>Any current substance or alcohol abuse, with the exception of nicotine.
  • \<TAB\>Positive urine toxicology screen
  • \<TAB\>Radiation exposure from participation in other research protocols or clinical care in the last year such that the additional radiation exposure from this protocol would exceed annual limits.
  • \<TAB\>Pregnancy or breastfeeding.
  • \<TAB\>Claustrophobia (Part 1 only).
  • \<TAB\>metallic (ferromagnetic) implants, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, shrapnel fragments, and possible small metal fragments in the eye (Part 1 only).
  • \<TAB\>Unable to lie flat on back for up to 2.5 hours.
  • \<TAB\>Positive HIV test.
  • \<TAB\>Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Kunishima N, Shimada Y, Tsuji Y, Sato T, Yamamoto M, Kumasaka T, Nakanishi S, Jingami H, Morikawa K. Structural basis of glutamate recognition by a dimeric metabotropic glutamate receptor. Nature. 2000 Oct 26;407(6807):971-7. doi: 10.1038/35039564.

    PMID: 11069170BACKGROUND

  • Conn PJ, Pin JP. Pharmacology and functions of metabotropic glutamate receptors. Annu Rev Pharmacol Toxicol. 1997;37:205-37. doi: 10.1146/annurev.pharmtox.37.1.205.

    PMID: 9131252BACKGROUND

  • Spooren W, Ballard T, Gasparini F, Amalric M, Mutel V, Schreiber R. Insight into the function of Group I and Group II metabotropic glutamate (mGlu) receptors: behavioural characterization and implications for the treatment of CNS disorders. Behav Pharmacol. 2003 Jul;14(4):257-77. doi: 10.1097/01.fbp.0000081783.35927.8f.

    PMID: 12838033BACKGROUND

Study Officials

  • Robert B Innis, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 22, 2011

Study Start

July 29, 2011

Primary Completion

November 27, 2012

Study Completion

November 27, 2012

Last Updated

December 16, 2019

Record last verified: 2012-11-27

Locations

US(1)