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

NCT ID: NCT03478020

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-22
• Study Completion Date: 2018-04-05

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).

Conditions

Healthy Volunteer

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-Treatment, Treatment Cycles A & B

Pre-Treatment: Two cycles of a combined oral contraceptive (COC) taken orally once daily for 21 days followed by 7 COC-free days.

Treatment Period A: COC containing taken orally once daily for 21 days followed by 7 COC-free days.

Treatment Period B: COC taken orally once daily for 21 days, with once daily oral 200 mg AQX-1125 (2 x 100 mg tablets) co-administered from Day 13 to 21, followed by 7 COC-free days

Group Type: EXPERIMENTAL

AQX-1125

Intervention Type: DRUG

Investigational Drug

Combined Oral Contraceptive

Intervention Type: DRUG

COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)

Interventions

AQX-1125

Investigational Drug

Intervention Type: DRUG

Combined Oral Contraceptive

COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aquinox Pharmaceuticals (Canada) Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeroen van de Wetering, MD

Role: PRINCIPAL_INVESTIGATOR

PRA Health Sciences

Locations

PRA Health Sciences - Early Development Serices

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

AQX-1125-104

Identifier Type: -

Identifier Source: org_study_id