Active Ingredient: SECNIDAZOLE
Secnidazole (SYM-1219 oral granules) demonstrates no clinically significant prolongation of cardiac repolarization or QTc intervals. In an ICH E14 thorough QT 4-way crossover trial in 52 healthy subjects with moxifloxacin positive control, single therapeutic (2 g) and supratherapeutic (6 g) doses showed no clinically relevant effect on QTcF, formally excluding prolongation exceeding 10 ms at all post-dose timepoints. Exposure-response modeling (slope 0.058 ms per ug/mL) predicts QTc changes remain below 10 ms up to plasma levels of ~125 ug/mL, approximately 3.4-fold higher than peak therapeutic concentrations.
https://doi.org/10.1002/jcph.1014, https://www.fda.gov/media/178811/download