Evaluation of Two Radioactive Chemicals to Image mGluR5 Receptors in Brain

NCT01896843 | Completed Phase 1

• 2 other identifiers: 13016613-M-0166
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- A small brain protein called the metabotropic glutamate receptor subtype 5 (mGluR5) may affect several brain diseases such as autism and depression. Researchers will use 2 radioactive chemicals (\[11C\]SP203 and \[11C\]FPEB) and a research drug (STX107) that can attach to the receptor, to figure out the best way to use positron emission tomography (PET) to see the mGluR5 receptor. They will use scans to monitor where the radioactivity goes. Objectives: \- To find the best way to image the mGluR5 receptor in the brain. Eligibility: \- Healthy volunteers ages 18 to 55. Design:

• All participants will be screened with a medical exam at visit 1. In later visits, they may have a PET scan, when two small tubes are placed under the skin and they lie down in a scanner. They may have an MRI scan, when they lie down in a scanner.
• Part 1 participants will have 2 more visits. They will have a PET brain scan using \[11C\]FPEB and will have blood drawn. Then they will have an MRI brain scan.
• Part 2 participants will have 1 more visit, with a whole body PET scan using \[11C\]FPEB and blood drawn.
• Part 3 participants will have 4 more visits, including 1 overnight stay at a hospital. Over all the visits, they will have 4 PET scans and 1 MRI brain scan. They will receive the research drug and injections of both chemicals. Blood will be drawn during the scans.

Conditions

mGluR5 Receptors

Keywords

Positron Emission Tomography (PET); Metabotropic Glutamate Receptors

Outcome Measures

Primary Outcomes (1)

• Peak brain uptake, Time-stability of distribution volume, Ratio of specific to non-displaceable brain uptake

  2 years

Interventions

STX107 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects between 18 to 55 yrs of age and able to give written informed consent.
• Subjects must be healthy based on medical history, physical examination and laboratory testing.

You may not qualify if:

• Any past or present Axis I psychiatric disorder. Any history of alcohol or substance dependence, except nicotine dependence, within the past 6 months
• Serious medical problems including but not limited to chronic neurological disease such as multiple sclerosis, autoimmune diseases, or serious cardiopulmonary disease.
• Active seizure disorder, as defined as having had a seizure in the past year or being on antiepileptic medications for seizures.
• Positive HIV test.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Metallic foreign bodies that would be affected by the MRI magnet or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
• Positive urine drug screen at time of enrollment.
• Pregnancy at time of scan (Beta-HCG will be measured in all female patients within 24 hours before start of scan and must be negative). Lactating women who are breast feeding.
• Prescription or over-the counter medication use; psychotropic herb use (e.g., St. John s Wort).

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Ametamey SM, Treyer V, Streffer J, Wyss MT, Schmidt M, Blagoev M, Hintermann S, Auberson Y, Gasparini F, Fischer UC, Buck A. Human PET studies of metabotropic glutamate receptor subtype 5 with 11C-ABP688. J Nucl Med. 2007 Feb;48(2):247-52.

  PMID: 17268022 BACKGROUND

• Backstrom P, Hyytia P. Ionotropic and metabotropic glutamate receptor antagonism attenuates cue-induced cocaine seeking. Neuropsychopharmacology. 2006 Apr;31(4):778-86. doi: 10.1038/sj.npp.1300845.

  PMID: 16123768 BACKGROUND

• Bear MF, Huber KM, Warren ST. The mGluR theory of fragile X mental retardation. Trends Neurosci. 2004 Jul;27(7):370-7. doi: 10.1016/j.tins.2004.04.009.

  PMID: 15219735 BACKGROUND

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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 11, 2013
• Study Start: June 27, 2013
• Primary Completion: June 16, 2016
• Study Completion: June 16, 2016
• Last Updated: September 27, 2018

Record last verified: 2017-01-11

Locations

US (1)