interstitial cystitis / bladder pain syndrome
Conditions
Interventions
Period Cycle Treatment
Pre-treatment Period Cycle 1 21 days COC followed by 7 COC-free days
Cycle 2 21 days COC followed by 7 COC-free days
Treatment Period A (TPA) Cycle 3 21 days COC followed by 7
Sponsors
Aquinox Pharmaceuticals (Canada) Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Gender : female of childbearing potential Age : 18-45 years, inclusive, at screening Body mass index (BMI) : 18.0-35.0 kg/m2
Exclusion criteria
Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Participation in a drug study within 30 days prior to screening. Participation in more than 2 other drug studies in the 10 months prior to (the first) drug administration in the current study. Donation or loss of more than 100 mL of blood within 60 days prior to the start of TPA on Day 1. Donation or loss of more than 1.0 liters of blood in the 10 months prior to the start of TPA on Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK variables will be the plasma concentrations of LNG, EE and AQX-1125 and their PK parameters. The PK parameters to be determined or calculated from the plasma concentration-time data for LNG, EE and AQX-1125 include but are not limited to the parameters as given below. Cmax Maximum observed plasma concentration tmax Time to attain maximum observed plasma concentration AUC0-24 Area under the plasma concentration-time curve up to 24 hours, kel Terminal elimination rate constant t1/2 Terminal elimination half-life, calculated as 0.693/kel | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety variables to be measured include but are not limited to the variables as given below. - AEs - Clinical laboratory - Vital signs - ECG - Physical examination | — |
Countries
Netherlands
Outcome results
None listed