NCT04484740

Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue

Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Gepotidacin is a new antibiotic that may potentially be used to treat prostatic infections and pharyngeal gonorrhoea. To date, no data exists on gepotidacin pharmacokinetics in those tissues. The present study is being carried out to determine concentrations of gepotidacin in plasma, prostate and tonsillar tissue of patients undergoing radical prostatectomy (RPE) for localized prostate, simple prostatectomy (PE) for benign prostate hyperplasia (BPH) or tonsillectomy (TE). This will contribute to a more complete understanding of the drug's penetration to its site of action.

Detailed description

A single dose of 1500 mg gepotidacin will be administered to patients who will undergo radical prostatectomy (RPE) or simple prostatectomy (PE) and patients undergoing tonsillectomy (TE). The individual time-points of gepotidacin administration will be chosen to ensure that the time-point of tissue removal corresponds with one of six different sampling time-points, as closely as possible. After study drug administration RPE or TE will be performed according to clinical routine. Subsequently, microdialysis (MD) probes will be inserted in the removed tissue (tonsillar or prostate tissue) ex-vivo and MD will be performed to determine unbound drug concentrations in the tissue. Plasma PK samples will be collected just before study drug administration and up to 48h after administration of gepotidacin. Since MD provides the concentration of the unbound fraction of gepotidacin, for comparison we will calculate the unbound fraction of the concentration values obtained through blood sampling. To this end, we will determine the protein binding using ultrafiltration for each subject at the time-point closest to the Cmax. The individual protein binding can then be used to calculate the unbound plasma fraction of gepotidacin. This will allow to transform the plasma PK data to the same scale as the microdialysis data. Samples will be analysed using non-compartmental analysis (NCA) for plasma concentrations and population pharmacokinetic models (PopPK) for tissue concentrations pooled with plasma concentrations.

Conditions

• Gonorrhea
• Infection, Bacterial

Interventions

Type	Name	Description
DRUG	Gepotidacin	Single oral dose of 1500 mg gepotidacin

Timeline

• Start date: 2021-01-29
• Primary completion: 2023-05-27
• Completion: 2023-05-27
• First posted: 2020-07-24
• Last updated: 2025-02-20

Locations

4 sites across 2 countries: Austria, France