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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559961
• Other study ID #: TTI-IC-0111-SAD
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2012
• Last updated: June 24, 2013
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Trillium Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

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

Intervention

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

Locations

Country	Name	City	State
Canada	Bramalea Medical Centre	Brampton	Ontario
Canada	Urology Associates/Urologic Medical Research	Kitchener	Ontario
Canada	The Fe/Male Health Centres	Oakville	Ontario
Canada	Urology & Male Fertility Clinic	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Trillium Therapeutics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of TTI-1612	Adverse events, physical examinations, ECGs, vital signs and clinical laboratory evaluations.	7 days	Yes
Secondary	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(0-8) - 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.	5 minutes to 48 hours post dosing	Yes