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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 is a Early Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 41 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01198197
The ClinicalTrials.gov registry entry for NCT01198197 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NOP-1A is the first listed.
NCT01198197 reports 0 study locations.
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.
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