NCT05491785

Cebranopadol Effects on Ventilatory Drive, Central Nervous System (CNS) and Pain.

Completed Phase 1 Last updated 9 May 2024

What this trial tests

Phase 1 trial testing Cebranopadol 600 µg in Pain in 30 participants. Completed in 2 January 2024.

Timeline

29 July 2022

Primary endpoint
30 March 2023

2 January 2024

Quick facts

Lead sponsor	Tris Pharma, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	29 July 2022
Primary completion	30 March 2023
Estimated completion	2 January 2024
Sites	2 locations across Netherlands

Drugs / interventions tested

• Cebranopadol 600 µg — full drug profile →
• Cebranopadol 800 µg — full drug profile →
• Cebranopadol 1000 µg — full drug profile →
• Oxycodone 30 mg — full drug profile →
• Oxycodone 60 mg — full drug profile →
• Placebo

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Tris Pharma, Inc. — full company profile →

Who can join

Adults 18 to 45, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nociceptin Receptor-Related Agonists as Safe and Non-addictive Analgesics.
   Ding H, Kiguchi N, Dobbins M, Romero-Sandoval EA, et al · · 2023 · cited 10× · PMID 37209211 · DOI 10.1007/s40265-023-01878-5