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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01559961
Date of registration: 15/03/2012
Prospective Registration: No
Primary sponsor: Trillium Therapeutics Inc.
Public title: Safety Study of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain Syndrome
Scientific 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
Date of first enrolment: March 2012
Target sample size: 28
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01559961
Study type:  Interventional
Study design:  Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
Canada
Contacts
Name:     Penka Petrova, PhD
Address: 
Telephone:
Email:
Affiliation:  Trillium Therapeutics Inc.
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Interstitial Cystitis
Intervention(s)
Drug: TTI-1612
Primary Outcome(s)
Safety and tolerability of TTI-1612 [Time Frame: 7 days]
Secondary Outcome(s)
Pharmacokinetics [Time Frame: 5 minutes to 48 hours post dosing]
Secondary ID(s)
TTI-IC-0111-SAD
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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