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

NCT01559961 | Completed Phase 1 DMC

• 1 other identifier: TTI-IC-0111-SAD
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

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.

Conditions

Interstitial Cystitis

Keywords

bladder; cystitis; frequency; nocturia; pain; urgency

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of TTI-1612

  Adverse events, physical examinations, ECGs, vital signs and clinical laboratory evaluations.

  7 days

Secondary Outcomes (1)

• Pharmacokinetics

  5 minutes to 48 hours post dosing

Study Arms (1)

TTI-1612

EXPERIMENTAL

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

Drug: TTI-1612

Interventions

TTI-1612 DRUG

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

TTI-1612

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trillium Therapeutics Inc.: lead

Study Sites (4)

Bramalea Medical Centre

Brampton, Ontario, L6T 4S5, Canada

Location

Urology Associates/Urologic Medical Research

Kitchener, Ontario, N2N 2B9, Canada

Location

The Fe/Male Health Centres

Oakville, Ontario, L6H 3P1, Canada

Location

Urology & Male Fertility Clinic

Toronto, Ontario, M1S 4V5, Canada

Location

MeSH Terms

Conditions

Cystitis, Interstitial; Cystitis; Nocturia; Pain

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Penka Petrova, PhD

  Trillium Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 21, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

CA (4)