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 个研究点目标入组 60 人开始时间: 2020年7月15日最近更新: 2021年4月5日

试验速览

暂无简介。

•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

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

发起方

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