Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study

Healthy Volunteer Clinical Trial

— DDI-COC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478020
• Other study ID #: AQX-1125-104
• Status: Completed
• Phase: Phase 1
• Start date: November 22, 2017
• Est. completion date: April 5, 2018

Study information

• Verified date: June 2018
• Source: Aquinox Pharmaceuticals (Canada) Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 5, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• AQX-1125
Investigational Drug
• Combined Oral Contraceptive
COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences - Early Development Serices	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Aquinox Pharmaceuticals (Canada) Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125	To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC	8 Weeks (from start of treatment period A to completion of treatment period B)
Primary	Time to attain maximum observed plasma concentration (tmax) of COC taken with AQX-1125	To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC	8 Weeks (from start of treatment period A to completion of treatment period B)
Primary	Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of COC taken with AQX-1125	To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC	8 Weeks (from start of treatment period A to completion of treatment period B)
Primary	Terminal elimination rate constant (Kel) of COC taken with AQX-1125	To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC	8 Weeks (from start of treatment period A to completion of treatment period B)
Primary	Terminal elimination half-life (t1/2) of COC taken with AQX-1125	To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC	8 Weeks (from start of treatment period A to completion of treatment period B)
Secondary	Safety and tolerability of AQX-1125 200 mg qd administered with the COC	Safety and tolerability will be assessed by the severity and frequency of adverse events, which will include any abnormal clinically significant vital signs, laboratory tests, electrocardiogram and physical examination findings	16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
Secondary	Maximum observed plasma concentration (Cmax) of AQX-1125 taken with COC	To assess the PK of 200 mg AQX-1125 qd when given together with the COC	8 Weeks (from start of treatment period A to completion of treatment period B)
Secondary	Time to attain maximum observed plasma concentration (tmax) of AQX-1125 taken with COC	To assess the PK of 200 mg AQX-1125 qd when given together with the COC	8 Weeks (from start of treatment period A to completion of treatment period B)
Secondary	Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of AQX-1125 taken with COC	To assess the PK of 200 mg AQX-1125 qd when given together with the COC	8 Weeks (from start of treatment period A to completion of treatment period B)
Secondary	Terminal elimination rate constant (Kel) of AQX-1125 taken with COC	To assess the PK of 200 mg AQX-1125 qd when given together with the COC	8 Weeks (from start of treatment period A to completion of treatment period B)
Secondary	Terminal elimination half-life (t1/2) of AQX-1125 taken with COC	To assess the PK of 200 mg AQX-1125 qd when given together with the COC	8 Weeks (from start of treatment period A to completion of treatment period B)