Safety Study of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain Syndrome

Interstitial Cystitis Clinical Trial

Official title: A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain Syndrome

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in women with interstitial cystitis/bladder pain syndrome.

Clinical Trial Description

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

• NCT number: NCT01559961
• Study type: Interventional
• Source: Trillium Therapeutics Inc.
• Status: Completed
• Phase: Phase 1
• Start date: March 2012
• Completion date: June 2013