Status:
COMPLETED
Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study
Lead Sponsor:
Aquinox Pharmaceuticals (Canada) Inc.
Conditions:
Healthy Volunteer
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
This is an open-label, fixed sequence, 4 cycle, drug-drug interaction (DDI) study of AQX-1125 in healthy female subjects on combination oral contraceptives (COC).
Eligibility Criteria
Inclusion
- Aged 18-45 years, inclusive, at time of signing Informed Consent
- Adult females of child bearing potential, who are non-pregnant and non-lactating, and must agree to use adequate additional contraception from the start of Treatment Period A until 90 days after the last dose of AQX-1125
- BMI 18.0 - 35.0 kg/m2
- Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the investigator
Exclusion
- Previous participation in the current study
- Any clinically significant history of breakthrough bleeding
- Using tobacco or other nicotine containing products within 12 months prior to the first study-specific COC-cycle intake
- History of alcohol abuse or drug addiction
- Positive drug and alcohol screen at screening and (each) admission to the clinical research center
- Average intake of more than 24 units of alcohol per week
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
- 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 Treatment Period A, on Day 1. Donation or loss of more than 1.0 liters of blood in the 10 months prior to the start of Treatment Period A, on Day 1
- Significant and/or acute illness within 5 days prior to Day 1 in Treatment Period A, that may impact safety assessments, in the opinion of the investigator
- Unsuitable veins for blood sampling
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03478020
Start Date
November 22 2017
End Date
April 5 2018
Last Update
June 13 2018
Active Locations (1)
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1
PRA Health Sciences - Early Development Serices
Groningen, Netherlands