Gepotidacin is a novel antibiotic currently under development. The objective of the project is to explore a potential new option for the treatment of pharyngeal Neisseria gonorrhoeae infections or prostatitis caused by Escherichia coli by demonstrating adequate penetration of a novel antibiotic in tonsillar and prostate tissues.
This will be achieved in the project by:
- Conducting in vivo studies to predict human exposures of gepotidacin in healthy and infected prostate;
- Measuring gepotidacin levels in tonsillar and prostate tissue by ex vivo microdialysis following single oral dose of gepotidacin in subjects undergoing elective tonsillectomy or prostatectomy;
- Refining the PBPK and the population pharmacokinetic (PopPK) models based on the generated clinical data to describe gepotidacin penetration into human tonsillar and prostate tissue;
- Developing a pharmacokinetic-pharmacodynamic (PKPD) model that relates the gepotidacin tissue exposure (PK) with the effect (PD) from time-kill curves using E. coli and N. gonorrhoeae;
- Determining the probability for target attainment for 90% of the subjects in plasma, prostate and tonsils based on data from microdialysis study healthy volunteers to support the evaluation of dosing regimens for each disease;
- Analysing the prostate non-clinical and clinical data, evaluate and contribute to the current understanding of translation across species.
