Urinary tract infections (UTIs) Urological and Genital Diseases
Conditions
Interventions
The study is divided into two parts:
Part A: Healthy volunteers will receive a single dose of the investigational drug (at different concentrations: D1, D2, or D3) or a sham control, in a random order
Sponsors
IBSA Institut Biochimique (Switzerland)
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before inclusion in the study. 2. Healthy women (Part A) or women with recurrent urinary tract infections (Part B), 18-55 years old inclusive 3. BMI: 18.5-30 kg/m2 inclusive 4. systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-99 bpm, measured after 5 min at rest in the sitting position 5. ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study 6. Contraception and fertility: women of child-bearing potential must be using at least one of the following reliable methods of contraception 6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit 6.2. A non-hormonal intrauterine device (IUD) or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit 6.3. A male sexual partner who agrees to use a male condom with spermicide 6.4. A sterile sexual partner 6.5. True abstinence Part B only: Women suffering from recurrent UTIs, in line with the European Urology Association guideline and the standard clinical practice at the site, diagnosed by a primary care physician or medical specialist, and who are in the quiescent phase of the disease, i.e., who are not presenting any UTI acute-onset symptoms that typically include dysuria in conjunction with variable degrees of increased urinary urgency and frequency, haematuria, and new or worsening incontinence
Exclusion criteria
Exclusion criteria: 1. ECG with clinically significant abnormalities 2. Clinically significant abnormal physical findings, presence of mouth lesions/alteration and of any tongue piercings, partials, braces, dentures 3. Lab analyses with clinically significant abnormalities 4. Ascertained or presumptive hypersensitivity to the active principle and/or formulation ingredients; history of anaphylaxis to drugs or allergic reactions 5. Significant diseases 6. Medications for 2 weeks before study start 7. Participation in the evaluation of any investigational product for 3 months before the study start 8. Blood donations for 3 months before this study 9. History of drug, alcohol, caffeine or tobacco abuse 10. Positive drug test at Day -1 11. Positive alcohol test at screening and Day -1 12. Abnormal diet 13. Positive or missing pregnancy test at screening or day-1, pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability measured using treatment-emergent adverse events, local tolerability at the instillation site, vital signs (blood pressure, heart rate), safety laboratory analysis, body weight, physical examination results at after single dose administration of the investigational product and sham control (only for study Part A) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile and parameters of diclofenac in plasma and urine measured using plasma diclofenac concentration-time profile and pharmacokinetic parameters (Cmax, AUC0-t, tmax, and, if feasible, %AUCextra, AUC0-8, t1/2 and ?Z); Urine diclofenac concentration-time profiles and pharmacokinetic parameters (Ae1-24, Ae1-4, Ae4-8, Ae8-12, Ae12-24, Fe1-t and Clr) at venous blood samples for PK on Days 1 and 2 at pre-dose (0), 0.5 (30 min), 1, 2, 3, 4, 6, 8, 10, 12, 14 and 24 h post-dose. Urine collection for evaluation of diclofenac concentration at following timepoints: Pre-dose , 1 h post-dose , 1-4 h post-dose, 4-8 h post-dose, 8-12 h post-dose, 12-24 h post-dose | — |
Countries
Switzerland
Contacts
Public ContactValeria Frangione
Outcome results
None listed