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Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue

NCT04484740 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-02-20

No results posted yet for this study

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.

Conditions

  • Gonorrhea
  • Infection, Bacterial

Interventions

DRUG

Gepotidacin

Single oral dose of 1500 mg gepotidacin

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-29
Primary Completion
2023-05-27
Completion
2023-05-27

Countries

  • Austria
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04484740 on ClinicalTrials.gov