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

Phase 1

• Conditions: Cohort A: Male patients with localized prostate cancer scheduled to undergo radical prostatectomy and patients with benign prostate hyperplasia scheduled to undergo simple prostatectomy Cohort B: Male and female patients undergoing complete tonsillectomy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2019-004308-37-FR
• Lead Sponsor: Institut National de la Santé et de la Recherche Médicale (INSERM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-15
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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
•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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:
•Pregnancy
•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)
?condoms
?sexual abstinence
?surgical sterilization
•Acute tonsillitis or peritonsillar abscess
•History of peritonsillar abscess
•Tonsillectomy for cervical lymph node metastasis of cancer of unknown primary

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified