PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A
Status:
Completed
Trial end date:
2014-02-28
Target enrollment:
Participant gender:
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.