placebo + moxifloxacin (Jazz Pharmaceuticals plc)

This refers to the control arm combination (negative and positive controls) used in the Phase 1 thorough QT/QTc (TQT) study (NCT01322139) for Sativex (nabiximols), which was developed by Jazz Pharmaceuticals (following the acquisition of GW Pharmaceuticals). In this randomized, double-blind, four-arm study, moxifloxacin (400 mg) was employed as the active positive control due to its established effect on cardiac repolarization (QT prolongation), ensuring the study's assay sensitivity. The placebo served as the negative control. The trial aimed to evaluate the electrophysiologic effects and safety of Sativex at therapeutic (8 sprays/day) and supratherapeutic (24 or 36 sprays/day) doses in healthy volunteers. Moxifloxacin is a fluoroquinolone antibiotic that inhibits DNA gyrase and topoisomerase IV, but in this context, it is utilized specifically for its known side effect of cardiac repolarization delay via hERG channel inhibition.

Other names

placebo and moxifloxacin controlactive and placebo control