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

NCT03478020 | Completed Phase 1

• 1 other identifier: AQX-1125-104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (6)

• Safety and tolerability of AQX-1125 200 mg qd administered with the COC

  16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)

• Maximum observed plasma concentration (Cmax) of AQX-1125 taken with COC

  8 Weeks (from start of treatment period A to completion of treatment period B)

• Time to attain maximum observed plasma concentration (tmax) of AQX-1125 taken with COC

  8 Weeks (from start of treatment period A to completion of treatment period B)

• Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of AQX-1125 taken with COC

  8 Weeks (from start of treatment period A to completion of treatment period B)

• Terminal elimination rate constant (Kel) of AQX-1125 taken with COC

  8 Weeks (from start of treatment period A to completion of treatment period B)

Study Arms (1)

Pre-Treatment, Treatment Cycles A & B

EXPERIMENTAL

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

Drug: AQX-1125; Drug: Combined Oral Contraceptive

Interventions

AQX-1125 DRUG

Investigational Drug

Pre-Treatment, Treatment Cycles A & B

Combined Oral Contraceptive DRUG

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

Pre-Treatment, Treatment Cycles A & B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pre-Menopausal Female Subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aquinox Pharmaceuticals (Canada) Inc.: lead

Study Sites (1)

PRA Health Sciences - Early Development Serices

Groningen, Netherlands

Location

MeSH Terms

Interventions

4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol; Contraceptives, Oral, Combined

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Jeroen van de Wetering, MD

  PRA Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 27, 2018
• Study Start: November 22, 2017
• Primary Completion: March 29, 2018
• Study Completion: April 5, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

NL (1)