Cebranopadol Effects on Ventilatory Drive, Central Nervous System (CNS) and Pain.
Status:
Recruiting
Trial end date:
2023-03-30
Target enrollment:
Participant gender:
Summary
Opioids are potent painkillers but come with serious adverse effects ranging from addiction
to potentially lethal respiratory depression via activation of μ-opioid receptors (MOP) at
specific sites in the central nervous system. Cebranopadol is a first-in-class
investigational drug to treat patients with acute and chronic pain. The molecule dually
activates the Nociceptin/Orphanin FQ peptide (NOP) receptor and the classical MOP receptor.
This is a unique mechanism of action and has demonstrated efficacy in multiple Phase 2 and
Phase 3 clinical studies across several nociceptive and neuropathic indications as well as a
superior safety profile, low potential for abuse and minimal risk of physical dependence. In
animal studies, cebranopadol produced considerably less respiratory depression at comparably
analgesic doses of oxycodone and fentanyl and appeared to have a ceiling to its respiratory
effects. Preliminary clinical trials have suggested that these results will be similar in
humans.
The present study is designed to investigate if: 1) cebranopadol produces less respiratory
depression than oxycodone 2) cebranopadol respiratory effects have a ceiling at very high
doses and 3) cebranopadol does not produce significant respiratory depression, as measured in
this study design with 30 subjects, at any dose in the VRH model.