Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue (NCT04484740) | Clinical Trial Compass
CompletedPhase 1
Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue
Austria, France53 participantsStarted 2021-01-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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)
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:
* Pregnanc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
area under the concentration time curve (AUC) from zero to last observed concentration (AUC0-t) in tissue
Timeframe: Baseline to 48 hours after drug administration
2
AUC from zero to infinity (AUC0-∞) in tissue
Timeframe: Baseline to 48 hours after drug administration
3
maximum drug concentration (Cmax) in tissue
Timeframe: Baseline to 48 hours after drug administration
4
half-life (t1/2) in tissue
Timeframe: Baseline to 48 hours after drug administration
5
time to reach maximum drug concentration (tmax) in tissue
Timeframe: Baseline to 48 hours after drug administration
Trial details
NCT IDNCT04484740
SponsorInstitut National de la Santé Et de la Recherche Médicale, France