Dose Selection for Phase III Clinical Evaluation of Gepotidacin (GSK2140944) in the Treatment of Uncomplicated Urinary Tract Infections
Nicole E. Scangarella-Oman, Mohammad Hossain, Jennifer L. Hoover, Caroline R. Perry, Courtney Tiffany, Aline Barth, Etienne F. Dumont
Abstract
animal efficacy, and pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) models that informed dose selection for phase III clinical evaluation of gepotidacin. Based on this translational package of data, a gepotidacin 1,500-mg oral dose twice daily for 5 days was selected for two ongoing, randomized, multicenter, parallel-group, double-blind, double-dummy, active-comparator phase III clinical studies evaluating the safety and efficacy of gepotidacin in adolescent and adult female participants with uUTIs (ClinicalTrials.gov identifiers NCT04020341 and NCT04187144).
Topics & Concepts
AntibioticsUrinary systemDNA gyraseMedicinePharmacokineticsTopoisomeraseInternal medicineClinical trialTopoisomerase IVPharmacologyAntibiotic resistanceSelection (genetic algorithm)Phases of clinical researchAntibacterial agentPharmacodynamicsFosfomycinDrug resistanceUrineIntensive care medicineClinical significanceUrologyMedical prescriptionDrugStaphylococcal infectionsUrinary Tract Infections ManagementPediatric Urology and Nephrology StudiesAntibiotics Pharmacokinetics and Efficacy