LAUSR

administration with a meal or soft foods, and the impact of high doses of secnidazole on cardiac safety. SYM-1219 was administered in either applesauce, yogurt, or pudding, followed by 240 mL of water. Serial blood samples were collected to determine secnidazole plasma concentrations and PK parameters for each treatment group are reported. Safety assessments, ECGs, and vital signs were performed during each study. An in vitro metabolism program, including CYP metabolism, inhibition, and induction, substrate and inhibition potential for transporters, and the potential for secnidazole to inhibit ethanol metabolism was performed. RESULTS: A single 2-g oral dose of SYM-1219 achieves an average maximum plasma secnidazole concentration (Cmax) of 35.7 to 46.3 mg/mL approximately 2 to 3 hours after dosing (Tmax). Exposure, as assessed by area under the plasma-concentration time curve (AUC), increases linearly with dose. Secnidazole has a prolonged terminal elimination half-life (t1/2) of w17 hours. SYM-1219 can be administered in applesauce, pudding, or yogurt and the timing and content of a meal does not have an impact on drug bioavailability. Secnidazole is not a substrate or inhibitor of transporters nor does it induce or inhibit hepatic CYP450 enzymes, therefore the potential for clinically important interactions with CYP450 substrates, inhibitors, or inducers is minimal. In a clinical study, secnidazole had negligible impact on the PK of ethinyl estradiol or norethindrone, suggesting that a single dose of SYM-1219 will not impact the efficacy of oral contraceptives. Secnidazole does not inhibit aldehyde dehydrogenase in vitro and therefore does not alter ethanol metabolism. There were no clinically significant abnormalities in laboratory, vital signs, or ECGs following administration of SYM-1219 to study subjects. CONCLUSIONS: The favorable safety and efficacy profile of SYM-1219, coupled with its PK characteristics, are the foundation for this single-dose oral treatment regimen for BV.