NCT01198197 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Berthele A, Platzer S, Dworzak D, Schadrack J, Mahal B, Büttner A, Assmus HP, Wurster K, Zieglgänsberger W, Conrad B, Tölle TR
[3H]-nociceptin ligand-binding and nociceptin opioid receptor mrna expression in the human brain. Neuroscience. 2003;121(3):629-40.
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.
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. Epub 2007 Nov 15.

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

Clinical trial NCT01198197 - References