Tris Pharma, Inc is starting a new clinical trial of Cebranopadol Effects on Ventilatory Drive, Central Nervous System (CNS) and Pain.
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.
This is a randomized, double blind, four period, six-treatment, double-dummy, placebo controlled, partial-crossover study will investigate the effects of cebranopadol on the ventilatory response to hypercapnia (VRH), nociceptive thresholds and safety. VRH testing is non-invasive and is an established technique to evaluate respiratory depression following the administration of opioids. The test will be performed using a rebreathing setup with the subjects comfortably seated or semi-supine in a hospital bed and breathing through a facemask. VRH will be performed at several timepoints post-administration of cebranopadol, oxycodone or placebo in a randomized fashion.
At each time point, subjects will be allowed an acclimation period of ambient air to establish regular breathing pattern; immediately followed by rebreathing a hypercapnic gas mixture (7%CO2, in oxygen (50%)), for at least 3 min. Between timepoints, subjects will remove their face masks and breathe ambient air.
The clinical trial started in July 29, 2022 and will continue throughout March 30, 2023.
Ventilatory response to hypercapnia (VRH) by maximum decrease in minute ventilation (L) will be primary outcome measure. Pre-dose to 24 h postdose.
For more details: https://ichgcp.net/clinical-trials-registry/NCT05491785.