Evaluation of Two Radioactive Chemicals to Image mGluR5 Receptors in Brain

Completed · Phase 1

Conditions studied: mGluR5 Receptors

In brief

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.

Key facts

Study ID

NCT01896843

Run by

National Institute of Mental Health (NIMH)

People needed

19

Starts

2013-06-27

Expected to finish

2016-06-16

Last updated by the study team

2018-09-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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).

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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