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

Purpose

The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in women with interstitial cystitis/bladder pain syndrome.

Condition	Intervention	Phase
Interstitial Cystitis	Drug: TTI-1612	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Interstitial Cystitis

U.S. FDA Resources

Further study details as provided by Trillium Therapeutics Inc.:

Primary Outcome Measures:

Safety and tolerability of TTI-1612 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Adverse events, physical examinations, ECGs, vital signs and clinical laboratory evaluations.

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: 5 minutes to 48 hours post dosing ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	28
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TTI-1612 Single intravesical 30-minute treatments with escalating doses of TTI-1612.	Drug: TTI-1612 Single intravesical 30-minute treatments with escalating doses of TTI-1612.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559961

Contacts

Contact: Michelle Gouveia	905-338-1078 ext 229	mgouveia@cmxres.com
Contact: Nada Dragicevic	1-866-666-3329

Locations

Canada, Ontario
Bramalea Medical Centre	Recruiting
Brampton, Ontario, Canada, L6T 4S5
Contact: Jonathan Giddens, MD 905-874-0092 jonathangiddens@hotmail.com
Principal Investigator: Jonathan Giddens, MD, FRCSC
Urology Associates/Urologic Medical Research	Recruiting
Kitchener, Ontario, Canada, N2N 2B9
Contact: Blair R Egerdie, MD, FRCSC 519-578-0470 blairegerdie@mac.com
Principal Investigator: Blair R Egerdie, MD, FRCSC
The Fe/Male Health Centres	Recruiting
Oakville, Ontario, Canada, L6H 3P1
Contact: Richard Casey, MD, FRCSC 905-338-3130 drcasey@bell.blackberry.net
Principal Investigator: Richard Casey, MD, FRCSC
Urology & Male Fertility Clinic	Recruiting
Toronto, Ontario, Canada, M1S 4V5
Contact: Allan Abramovitch, MD, FRCSC 416-754-1019 abramresearch@gmail.com
Principal Investigator: Allan Abramovitch, MD, FRCSC

Sponsors and Collaborators

Trillium Therapeutics Inc.

Investigators

Study Director:

Penka Petrova, PhD

Trillium Therapeutics Inc.

More Information

No publications provided

Responsible Party:	Trillium Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT01559961 History of Changes
Other Study ID Numbers:	TTI-IC-0111-SAD
Study First Received:	March 15, 2012
Last Updated:	September 19, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Trillium Therapeutics Inc.:

bladder
cystitis
frequency

nocturia
pain
urgency

Additional relevant MeSH terms:

Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013