The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in women with interstitial cystitis/bladder pain syndrome.
Single doses of TTI-1612, at seven escalating dose levels, will be administered intravesically to women with IC/BPS. Drug will be retained in the bladder for 30 minutes. TTI-1612 pharmacokinetics will be studied through the collection of blood samples at various time points, from 5 minutes to 8 hours post administration on dosing day, then at 24 and 48 hours post dosing. Serum will be isolated for subsequent analysis and determination of the following parameters: maximum serum concentration (Cmax), time of maximum observed concentration (Tmax), area under the curve to the final time with a concentration above the limit of quantification (AUC 0-t) and to infinity (AUC 0-∞), elimination half-life (t½), clearance (CL) and volume of distribution (Vz). TTI-1612 safety will be determined through monitoring of the subjects' vital signs, ECGs, clinical laboratory evaluations, adverse events (if any) and physical examinations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Single intravesical 30-minute treatments with escalating doses of TTI-1612.
Bramalea Medical Centre
Brampton, Ontario, Canada
Urology Associates/Urologic Medical Research
Kitchener, Ontario, Canada
The Fe/Male Health Centres
Oakville, Ontario, Canada
Urology & Male Fertility Clinic
Toronto, Ontario, Canada
Safety and tolerability of TTI-1612
Adverse events, physical examinations, ECGs, vital signs and clinical laboratory evaluations.
Time frame: 7 days
Pharmacokinetics
Blood samples will be obtained pre-dose, at 5, 10, 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24, 48 hours post dosing. Serum will be analyzed for levels of TTI-1612. The following parameters will be evaluated: * C(max) - maximum concentration, * T(max) - time to maximum concentration, * AUC(0-t) - area under the curve from time zero to the final time with a concentration above the limit of quantification, * AUC(0-∞) - area under the curve from time zero to infinity, * T(1/2) - elimination half-life, * CL - clearance, * V(z) - volume of distribution during the terminal phase.
Time frame: 5 minutes to 48 hours post dosing
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