Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue

NCT04484740 | Completed Phase 1

• 2 other identifiers: C19-282019-004308-37
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

tissue pharmacokinetics; gepotidacin; microdialysis

Outcome Measures

Primary Outcomes (5)

• area under the concentration time curve (AUC) from zero to last observed concentration (AUC0-t) in tissue

  Pharmacokinetic parameters in tissue calculated using a population pharmacokinetic model

  Baseline to 48 hours after drug administration

• AUC from zero to infinity (AUC0-∞) in tissue

  Pharmacokinetic parameters in tissue calculated using a population pharmacokinetic model

  Baseline to 48 hours after drug administration

• maximum drug concentration (Cmax) in tissue

  Pharmacokinetic parameters in tissue calculated using a population pharmacokinetic model

  Baseline to 48 hours after drug administration

• half-life (t1/2) in tissue

  Pharmacokinetic parameters in tissue calculated using a population pharmacokinetic model

  Baseline to 48 hours after drug administration

• time to reach maximum drug concentration (tmax) in tissue

  Pharmacokinetic parameters in tissue calculated using a population pharmacokinetic model

  Baseline to 48 hours after drug administration

Secondary Outcomes (11)

• area under the concentration time curve (AUC) from zero to last observed concentration (AUC0-t) in plasma

  Baseline to 48 hours after drug administration

• AUC from zero to infinity (AUC0-∞) in plasma

  Baseline to 48 hours after drug administration

• Cmax in plasma

  Baseline to 48 hours after drug administration

• t1/2 in plasma

  Baseline to 48 hours after drug administration

• tmax in plasma

  Baseline to 48 hours after drug administration

Study Arms (1)

Gepotidacin

EXPERIMENTAL

Drug: Gepotidacin

Interventions

Gepotidacin DRUG

Single oral dose of 1500 mg gepotidacin

Gepotidacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort A only:
• Clinically localized prostate cancer or benign prostate hyperplasia
• Male patient scheduled for prostatectomy
• Cohort B only:
• Male or female patient scheduled for complete tonsillectomy
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP) or
• Is a WOCBP with a highly sensitive negative pregnancy test
• Both Cohorts:
• Age: above 18 years
• Body weight ≥40 kg and body mass index (BMI) within the range 18.5 - 32.0 kg/m2
• A signed and dated written informed consent form
• The subject is able to understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions
• Negative serology (human immunodeficiency virus, hepatitis B-AG and C-AB) at screening
• Patient with a social security or health insurance (if applicable according to the local regulation)

You may not qualify if:

• Cohort A only:
• Any concerns of the investigator or the treating urologists that the participation in the study might impair histological assessment of the prostate tissue such as (but not limited to): lack of representative histology via previous biopsy AND inability to safely insert microdialysis probes in tissue with sufficient distance to the tumor (e.g. large or diffuse tumor, lack of MRI or PET image to locate tumor within the organ).
• Cohort B only:
• Pregnancy
• Women of childbearing potential who are not employing adequate contraceptive measures
• Accepted contraceptive measures are (have to be employed for at least 30 days prior to dosing until one week after the final examination):
• intrauterine device
• intrauterine hormone-releasing system
• implantable progestogen-only hormone contraception associated with inhibition of ovulation
• combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable)
• progestogen-only hormone contraception associated with inhibition of ovulation (oral, injectable)
• condoms
• sexual abstinence
• surgical sterilization
• Acute tonsillitis or peritonsillar abscess

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Medical University of Vienna: collaborator

Study Sites (4)

MUVienna

Vienna, 1090, Austria

Location

CHU POITIERS Département ORL

Poitiers, 86021, France

Location

CHU POITIERS Département Urologie

Poitiers, 86021, France

Location

CHRU TOURS Département Urologie

Tours, 37000, France

Location

MeSH Terms

Conditions

Gonorrhea; Bacterial Infections

Interventions

gepotidacin

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 24, 2020
• Study Start: January 29, 2021
• Primary Completion: May 27, 2023
• Study Completion: May 27, 2023
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

FR (3); AU (1)