Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01559961 |
Date of registration:
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15/03/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Safety Study of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain Syndrome
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Scientific title:
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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:
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March 2012 |
Target sample size:
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28 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01559961 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Contacts
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Name:
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Penka Petrova, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Trillium Therapeutics Inc. |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis
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Intervention(s)
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Drug: TTI-1612
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Primary Outcome(s)
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Safety and tolerability of TTI-1612
[Time Frame: 7 days]
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Secondary Outcome(s)
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Pharmacokinetics
[Time Frame: 5 minutes to 48 hours post dosing]
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Secondary ID(s)
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TTI-IC-0111-SAD
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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