Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-30 @ 2:26 AM
Study NCT ID:
NCT01559961
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2012-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain Syndrome
Sponsor:
Trillium Therapeutics Inc.
Organization:
Study Overview
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
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in women with interstitial cystitis/bladder pain syndrome.
Detailed 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: