Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-24 @ 12:12 PM
NCT ID:
NCT01559961
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01559961
Study Brief:
Protocol Section:
NCT01559961