Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT03478020
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03478020
Study Brief:
Protocol Section:
NCT03478020