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Clinical Trials/EUCTR2019-004308-37-FR
EUCTR2019-004308-37-FR
Active, not recruiting
Phase 1

Penetration of the innovative antibiotic gepotidacin into prostate and tonsillar tissue. - AB-DiRecT

Institut National de la Santé et de la Recherche Médicale (INSERM)0 sites60 target enrollmentJuly 15, 2020
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Institut National de la Santé et de la Recherche Médicale (INSERM)
Enrollment
60
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 15, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Institut National de la Santé et de la Recherche Médicale (INSERM)

Eligibility Criteria

Inclusion Criteria

  • •Cohort A only:
  • •Clinically localized prostate cancer or benign prostate hyperplasia
  • •Man undergoing a 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:
  • •oIs not a woman of childbearing potential (WOCBP) or
  • •oIs a WOCBP with a highly sensitive negative pregnancy test
  • •Both Cohorts:
  • •Age: above 18 years

Exclusion Criteria

  • •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:
  • •Women of childbearing potential who are not employing adequate contraceptive measures
  • •oAccepted 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)

Outcomes

Primary Outcomes

Not specified

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