AzTrials
AzTrials

DosimetryPhase 1NCT01420952

Imaging of Brain Receptors Using (11C)mGlu1

A Phase 1 study testing [11C]LY2428703 in people with Dosimetry and Pharmacokinetics, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Dosimetry, Pharmacokinetics
What is being tested?
[11C]LY2428703
How many people
3 participants
Where
1 siteUnited States
Study dates
29 Jul 2011to 27 Nov 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • <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.
Show all 12Show fewer
  • <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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: PET Imaging of Brain mGlu1 Receptors Using [11]LY2428703

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.
Read more

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.
Read the detailed description

Metabotropic glutamate receptors (mGluRs) are G-protein coupled receptors that respond to glutamate by activating proteins inside nerve cells that affect cell metabolism, thereby fine-tuning the signals sent between cells to maintain balance in neuronal activity. mGluR receptor subtype 1 (mGluR1s) are located in several brain regions, including the cerebellum, hippocampus, olfactory bulb, and basal ganglia. mGluR1 activation stimulates phospholipase C, resulting in phosphoinositide hydrolysis and increased intracellular Ca(2+) levels. Detailed study of mGluR1s has heretofore been hindered by the lack of high affinity and of selective ligands for this receptor subtype.

The present protocol will use a new PET ligand [C(11)]mGlu1 to 1) perform kinetic brain imaging to quantify mGluR1 binding parameters in brain and determine the reliability and reproducibility of these measures in 15 healthy volunteers (Phase 1); and 2) if the tracer proves successful in Phase 1, we will estimate radiation-absorbed doses of [C(11)]mGlu1 in healthy human subjects by performing whole body imaging (Phase 2).

Successful development of a PET ligand to image mGlurR1 would have a strong impact on clinical management of brain disorders characterized by disruptions in glutamatergic transmission, including anxiety and stress disorders, drug addiction, epilepsy, Huntington s disease, and Parkinson s disease.

Being tested
[11C]LY2428703
Keywords
Positron Emission Tomograhy (PET), Metabolic Glutamate Receptors, Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [11C]LY2428703Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2011 (estimated)
  2. Study start29 Jul 2011
  3. Primary completion27 Nov 2012
  4. Study completion27 Nov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01420952
Sponsor's protocol ID
110229
Other IDs
11-M-0229
Status last verified
27 Nov 2012
First submitted
19 Aug 2011
Last updated
16 Dec 2019
Results posted
No

Publications

  • 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.

    PubMed 11069170

  • 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.

    PubMed 9131252

  • 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.

    PubMed 12838033

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [11C]LY2428703 in people with Dosimetry and Pharmacokinetics, run by National Institute of Mental Health (NIMH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01420952, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in