At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [(11)C]NOP-1A
In Brief
A Early Phase 1 clinical trial evaluating NOP-1A for Pain and 2 related conditions. Completed, enrolled 41 participants across 1 site.
Detailed 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.