PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A

NCT01198197 | Completed Early Phase 1

• 2 other identifiers: 10020410-M-0204
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- A small brain protein called nociceptin/orphanin FQ peptide (NOP) receptor may be involved in several brain diseases such as anxiety, depression, drug abuse, and seizures. Researchers are interested in testing a new radioactive chemical that will help locate NOP receptors in the brain during imaging studies such as positron emission tomography (PET) scans. Because this chemical has not yet been approved by the Food and Drug Administration, it is considered to be an experimental drug. Objectives: \- To investigate the effectiveness of the experimental chemical \[11C\]NOP-1A in imaging studies of the nociceptin/orphanin FQ peptide (NOP) receptor. Eligibility: \- Healthy volunteers between 18 and 50 years of age who are able to have imaging studies. Design:

• This study will involve three or four outpatient visits to the National Institutes of Health Clinical Center. All participants will be screened with a full physical examination, medical history, blood and urine tests, and electrocardiogram.
• Participants will be involved in one or more parts of this three-part study as directed by study researchers. Part 1 consists of brain imaging to study how the brain responds to the chemical. Part 2 is a whole body imaging study to evaluate how the chemical is distributed throughout the body after being administered. Part 3 is a set of testing and retesting scans to determine how precise the drug is in locating the NOP receptors in the brain.
• Part 1: Participants will have a brain magnetic resonance imaging (MRI) scan. Then the study drug will be administered and participants will have a brain PET scan. Blood samples will be taken during the PET scan, and urine samples will be taken after the scan. These tests will take up to 3 hours to perform.
• Part 2: Participants will have a whole body PET scan that will last a maximum of 3 hours.
• Part 3: Participants will receive the study drug and have two additional PET scans. Blood samples will also be taken during this part.

Conditions

Pain; Anxiety; Depression

Keywords

Nociceptin/Orphanin FQ Peptide (NOP); PET Imaging; Brain Imaging; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• For the PET scans, we will measure the regional densities of NOP receptors as distribution volume (VT). Distribution volume is the ratio at equilibrium of brain uptake to the concentration of parent radioligand in plasma.

  2 years

Interventions

NOP-1A DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Volunteers:
• Subjects must be adults between 18-50 years old.
• Subjects must be able and willing to give written informed consent.

You may not qualify if:

• Current psychiatric illness or severe systemic disease based on history and physical exam.
• If women, pregnancy or breast feeding (betaHCG will be measured in all female patients within 24 hours of scan and must be negative)
• Clinically significant laboratory abnormalities.
• Serious medical problems including but not limited to chronic neurological disease such as multiple sclerosis, autoimmune diseases or any cardiopulmonary disease.
• Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Positive urine drug screen at screening.
• Inability to lie flat on camera bed for about 2.5 hours
• Subjects who have 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.

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)

• Berthele A, Platzer S, Dworzak D, Schadrack J, Mahal B, Buttner A, Assmus HP, Wurster K, Zieglgansberger W, Conrad B, Tolle TR. [3H]-nociceptin ligand-binding and nociceptin opioid receptor mrna expression in the human brain. Neuroscience. 2003;121(3):629-40. doi: 10.1016/s0306-4522(03)00484-6.

  PMID: 14568023 BACKGROUND

• Bridge KE, Wainwright A, Reilly K, Oliver KR. Autoradiographic localization of (125)i[Tyr(14)] nociceptin/orphanin FQ binding sites in macaque primate CNS. Neuroscience. 2003;118(2):513-23. doi: 10.1016/s0306-4522(02)00927-2.

  PMID: 12699786 BACKGROUND

• Brown AK, Fujita M, Fujimura Y, Liow JS, Stabin M, Ryu YH, Imaizumi M, Hong J, Pike VW, Innis RB. Radiation dosimetry and biodistribution in monkey and man of 11C-PBR28: a PET radioligand to image inflammation. J Nucl Med. 2007 Dec;48(12):2072-9. doi: 10.2967/jnumed.107.044842. Epub 2007 Nov 15.

  PMID: 18006619 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders; Depression

Interventions

3-(2'-fluoro-6',7'-dihydrospiro(piperidine-4,4'-thieno(3,2-c)pyran)-1-yl)-2-(2-fluorobenzyl)-N-methylpropanamide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Masahiro Fujita, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 9, 2010
• Study Start: September 3, 2010
• Study Completion: February 28, 2014
• Last Updated: December 17, 2019

Record last verified: 2014-09-05

Locations

US (1)