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

Primary Purpose

Interstitial Cystitis

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
TTI-1612
Sponsored by
Trillium Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring bladder, cystitis, frequency, nocturia, pain, urgency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is female, 18 to 65 years old, inclusive.
  • Subject has read and signed an ICF.
  • Subject has BMI of 18 to 32kg/sq.m., inclusive.
  • Subject has been diagnosed with IC/BPS, according to current AUA guidelines for IC/BPS.
  • Subjects of child-bearing potential must agree: (1) to a double-barrier contraception method between screening and baseline visits, and (2) to abstain from sexual intercourse from baseline visit through to study completion (day 7 +/- 1 day).
  • Subject has a negative serum pregnancy test at screening and at baseline.
  • Subject is not lactating.
  • Subject has documented negative antibody tests for HIV, HbSAg or HCV within 3 months prior to dosing or tests negative at screening.
  • Subject tests negative for bladder cancer by cystoscopy within 6 months prior to dosing and tests negative by urine cytology at screening.
  • Subject has clinical laboratory values (CBCs, comprehensive metabolic panel and urinalysis) that fall within normal ranges or are not clinically significant in the opinion of the Investigator.

Exclusion Criteria:

  • Subject has a history of oncologic disease except non-melanoma skin cancer.
  • Subject has any other condition that, in the opinion of the Investigator, may jeopardize the safety of the subject or may impact the validity of the study results.
  • Subject, for whatever reason, has had substantial changes in eating habits within 30 days prior to dosing, which, in the opinion of the Investigator, may confound the planned PK evaluations or interpretation of the results of the study.
  • Subject has donated blood within 30 days or plasma within 14 days prior to dosing.
  • Subject has used intravesical therapy within 3 months prior to dosing.
  • Subject is receiving non-stable therapy for IC/BPS (stable therapy is defined as continuous treatment for at least 6 months).
  • Subject has used an investigational agent within 3 months prior to dosing.
  • Subject has an ECG or vital signs at baseline that, in the opinion of the Investigator or Sponsor, is/are clinically significant.
  • Subject has consumed alcohol, grapefruit, grapefruit juice or xanthine-containing beverages or foods within 48 hours prior to dosing.
  • Subject has taken any known hepatic enzyme-altering drugs within 30 days prior to dosing.
  • Subject has taken any known heparin-containing drugs within 30 days prior to dosing.

Sites / Locations

  • Bramalea Medical Centre
  • Urology Associates/Urologic Medical Research
  • The Fe/Male Health Centres
  • Urology & Male Fertility Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TTI-1612

Arm Description

Single intravesical 30-minute treatments with escalating doses of TTI-1612.

Outcomes

Primary Outcome Measures

Safety and tolerability of TTI-1612
Adverse events, physical examinations, ECGs, vital signs and clinical laboratory evaluations.

Secondary Outcome Measures

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.

Full Information

First Posted
March 15, 2012
Last Updated
June 24, 2013
Sponsor
Trillium Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01559961
Brief Title
Safety Study of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trillium Therapeutics Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
bladder, cystitis, frequency, nocturia, pain, urgency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TTI-1612
Arm Type
Experimental
Arm Description
Single intravesical 30-minute treatments with escalating doses of TTI-1612.
Intervention Type
Drug
Intervention Name(s)
TTI-1612
Intervention Description
Single intravesical 30-minute treatments with escalating doses of TTI-1612.
Primary Outcome Measure Information:
Title
Safety and tolerability of TTI-1612
Description
Adverse events, physical examinations, ECGs, vital signs and clinical laboratory evaluations.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is female, 18 to 65 years old, inclusive. Subject has read and signed an ICF. Subject has BMI of 18 to 32kg/sq.m., inclusive. Subject has been diagnosed with IC/BPS, according to current AUA guidelines for IC/BPS. Subjects of child-bearing potential must agree: (1) to a double-barrier contraception method between screening and baseline visits, and (2) to abstain from sexual intercourse from baseline visit through to study completion (day 7 +/- 1 day). Subject has a negative serum pregnancy test at screening and at baseline. Subject is not lactating. Subject has documented negative antibody tests for HIV, HbSAg or HCV within 3 months prior to dosing or tests negative at screening. Subject tests negative for bladder cancer by cystoscopy within 6 months prior to dosing and tests negative by urine cytology at screening. Subject has clinical laboratory values (CBCs, comprehensive metabolic panel and urinalysis) that fall within normal ranges or are not clinically significant in the opinion of the Investigator. Exclusion Criteria: Subject has a history of oncologic disease except non-melanoma skin cancer. Subject has any other condition that, in the opinion of the Investigator, may jeopardize the safety of the subject or may impact the validity of the study results. Subject, for whatever reason, has had substantial changes in eating habits within 30 days prior to dosing, which, in the opinion of the Investigator, may confound the planned PK evaluations or interpretation of the results of the study. Subject has donated blood within 30 days or plasma within 14 days prior to dosing. Subject has used intravesical therapy within 3 months prior to dosing. Subject is receiving non-stable therapy for IC/BPS (stable therapy is defined as continuous treatment for at least 6 months). Subject has used an investigational agent within 3 months prior to dosing. Subject has an ECG or vital signs at baseline that, in the opinion of the Investigator or Sponsor, is/are clinically significant. Subject has consumed alcohol, grapefruit, grapefruit juice or xanthine-containing beverages or foods within 48 hours prior to dosing. Subject has taken any known hepatic enzyme-altering drugs within 30 days prior to dosing. Subject has taken any known heparin-containing drugs within 30 days prior to dosing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penka Petrova, PhD
Organizational Affiliation
Trillium Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Bramalea Medical Centre
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 4S5
Country
Canada
Facility Name
Urology Associates/Urologic Medical Research
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
The Fe/Male Health Centres
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Urology & Male Fertility Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1S 4V5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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