Clinical trial NCT03478020: Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study
Official title: Open-Label, Fixed-Sequence 3-Period Study to Determine the Effects of Repeated Oral Dosing of AQX-1125 on the Pharamacokinetics, Safety and Tolerability of a Combination Oral Contraceptive in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Aquinox Pharmaceuticals (Canada) Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125
timeFrame: 8 Weeks (from start of treatment period A to completion of treatment period B)
measure: Time to attain maximum observed plasma concentration (tmax) of COC taken with AQX-1125
timeFrame: 8 Weeks (from start of treatment period A to completion of treatment period B)
measure: Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of COC taken with AQX-1125
timeFrame: 8 Weeks (from start of treatment period A to completion of treatment period B)
measure: Terminal elimination rate constant (Kel) of COC taken with AQX-1125
timeFrame: 8 Weeks (from start of treatment period A to completion of treatment period B)
measure: Terminal elimination half-life (t1/2) of COC taken with AQX-1125
timeFrame: 8 Weeks (from start of treatment period A to completion of treatment period B)
Secondary outcomes:
measure: Safety and tolerability of AQX-1125 200 mg qd administered with the COC
timeFrame: 16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
measure: Maximum observed plasma concentration (Cmax) of AQX-1125 taken with COC
timeFrame: 8 Weeks (from start of treatment period A to completion of treatment period B)
measure: Time to attain maximum observed plasma concentration (tmax) of AQX-1125 taken with COC
timeFrame: 8 Weeks (from start of treatment period A to completion of treatment period B)
measure: Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of AQX-1125 taken with COC
timeFrame: 8 Weeks (from start of treatment period A to completion of treatment period B)
measure: Terminal elimination rate constant (Kel) of AQX-1125 taken with COC
timeFrame: 8 Weeks (from start of treatment period A to completion of treatment period B)
measure: Terminal elimination half-life (t1/2) of AQX-1125 taken with COC
timeFrame: 8 Weeks (from start of treatment period A to completion of treatment period B)
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences - Early Development Serices
Study officials:
affiliation: PRA Health Sciences
name: Jeroen van de Wetering, MD
role: PRINCIPAL_INVESTIGATOR
References: