Active Ingredient: ORITAVANCINE
In a Phase I, randomized, placebo- and positive-controlled parallel Thorough QT study of 150 healthy volunteers, a supratherapeutic IV dose of 1600 mg was evaluated against moxifloxacin. Baseline- and placebo-corrected QTcF showed no prolongation. A slight, clinically insignificant increase in PR interval at 1 hour post-infusion was observed, with PK-PD modeling predicting a 3.2ms change at therapeutic doses (1200 mg). A single therapeutic dose of 1200 mg is not expected to exert any cardiotoxic effect.
https://doi.org/10.1002/cpdd.268