Interstitial CystitisPhase 1NCT01559961
Safety Study of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain Syndrome
A Phase 1 study testing TTI-1612 in people with Interstitial Cystitis, run by Trillium Therapeutics Inc. at 4 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- TTI-1612
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesCanada
- Study dates
- Mar 2012to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Bramalea Medical Centre
Brampton, Ontario, L6T 4S5
Urology Associates/Urologic Medical Research
Kitchener, Ontario, N2N 2B9
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1
Urology & Male Fertility Clinic
Toronto, Ontario, M1S 4V5
About this study
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
The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in women with interstitial cystitis/bladder pain syndrome.
Read the 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.
- Conditions
- Interstitial Cystitis
- Being tested
- TTI-1612
- Keywords
- bladder, cystitis, frequency, nocturia, pain, urgency
- Medical subject headings
- Cystitis, Interstitial, Cystitis, Nocturia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTI-1612Drug
Single intravesical 30-minute treatments with escalating doses of TTI-1612.
| Study group | Role | What they receive |
|---|---|---|
| TTI-1612 | Experimental | Single intravesical 30-minute treatments with escalating doses of TTI-1612. Receives: Drug: TTI-1612 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of TTI-1612
Adverse events, physical examinations, ECGs, vital signs and clinical laboratory evaluations.
Measured: 7 days
Secondary outcomes (1)
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-∞) - 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.
Measured: 5 minutes to 48 hours post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trillium Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Penka Petrova, PhD, Study director, Trillium Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559961
- Sponsor's protocol ID
- TTI-IC-0111-SAD
- Status last verified
- Jun 2013
- First submitted
- 15 Mar 2012
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01559961
- Acronym / sponsor ID
- TTI-IC-0111-SAD
- Conditions
- Interstitial Cystitis
- Keywords
- bladder, cystitis, frequency, nocturia, pain, urgency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Trillium Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in women with interstitial cystitis/bladder pain syndrome.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTI-1612 | Experimental | Drug: TTI-1612Single intravesical 30-minute treatments with escalating doses of TTI-1612. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTI-1612Single intravesical 30-minute treatments with escalating doses of TTI-1612. | Drug | TTI-1612 |
Primary outcome
Safety and tolerability of TTI-1612
Time frame: 7 days
Adverse events, physical examinations, ECGs, vital signs and clinical laboratory evaluations.
1 secondary outcome
Pharmacokinetics
Time frame: 5 minutes to 48 hours post dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penka Petrova, PhD study director
Trillium Therapeutics Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TTI-1612 in people with Interstitial Cystitis, run by Trillium Therapeutics Inc. at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of TTI-1612 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.