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NCT01198197 · ClinicalTrials.gov registry record · Early Phase 1
PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A
A Early Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 41
- Enrollment target
NCT01198197: Completed Early Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
NCT01198197 is a Early Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 41 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01198197, a Early Phase 1 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 41 participants
- Enrollment target
Study 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
Interventions
- DRUG NOP-1A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2010-09-03 |
| Est. Completion | 2014-02-28 |
| Phase | Early Phase 1 |
What the finished NCT01198197 record still lists
NCT01198197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which NOP-1A is the first listed.
NCT01198197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01198197 about?
NCT01198197 is a clinical study titled "PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A". 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 brai...
What is the current status of trial NCT01198197?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 41 participants. The study started on 2010-09-03. Estimated completion is 2014-02-28.
What interventions are being tested in trial NCT01198197?
The interventions under investigation include: NOP-1A (DRUG).
Who is sponsoring clinical trial NCT01198197?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01198197's enrollment target sits among peer trials
41 623rd of 2000 higher than 1,373 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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