US-based pharmaceutical firm Trevena has started the next Phase I trial for TRV734, a new drug candidate being developed as an orally administered treatment for moderate-to-severe acute and chronic pain.
The company is currently developing TRV734 to optimise analgesia while reducing on-target adverse effects on the gastrointestinal and central nervous systems through its new biased ligand mechanism at the mu-opioid receptor.
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The company said that TRV734 takes advantage of the same receptor specificity mechanism as its Phase II clinical compound TRV130, an intravenous mu-opioid G protein biased ligand being developed for acute postoperative pain.
The trial is designed to assess the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 administered as a single dose and as multiple ascending doses in healthy volunteers.
Top-line data from the Phase I trial, aimed at supporting Phase II development, is expected to be reported in the first half of 2015.
Around 72 healthy volunteers will be enrolled in the trial, which will be conducted in two parts.
Part A of the trial will evaluate the safety, tolerability, PD and PK of single 125mg doses of TRV734 in an open-label, randomised, three-period crossover study in which subjects are fasted, fed a standard meal or fed a high-fat meal.
This part of the trial is designed to explore how changes in absorption may modify the performance of TRV734 and to identify the best administration paradigm for part B.
Part B will evaluate the safety, tolerability, PD and PK of multiple ascending doses of TRV734 in a double-blind, double-dummy, randomised, active- and placebo-controlled adaptive study.
In this part, oxycodone immediate release 10mg will be used as a benchmark for a variety of pharmacodynamic measures intended to evaluate the analgesic and adverse effect profile of TRV734.
Trevena chief executive officer Maxine Gowen said: "This study builds on our recent positive Phase I data, and will explore dose regimens of TRV734 using a series of validated experimental measures to support subsequent Phase II development.
"We believe that TRV734 could replace current opioid analgesics by offering improved pain relief with reduced incidence and severity of opioid-related adverse effects."
