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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT06657105
Eligibility Criteria:
Inclusion Criteria:
* Females must have a negative pregnancy test at the Screening Visit and Study Day -1 (admission to Clinical Unit) and must not be lactating and must be of non-childbearing potential, confirmed at Screening by fulfilling one of the following criteria:
1. Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range (Follicular Stimulating Hormone (FSH) \> 40 mIU/mL).
2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
* Have a Body Mass Index (BMI) between 18 and 30 kg/m2
Exclusion Criteria:
* History of any clinically important disease or disorder which, in the opinion of the Investigator
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Sex hormone therapy within one month before study.
* History of drug-related hepatic toxicity.
* History or family history of potential risk of arterial and venous thromboembolic events (eg, factor V Leiden mutation).
* History of cardiovascular risk (eg, history of myocardial infarction).
* Any laboratory values with the following deviations at the Screening Visit and Study Day -1 (admission to Clinical Unit).
* Any positive result on screening for serum HBsAg, HBcAb, HCV or HIV.
* History of any treatment with QT prolongation drugs.
* Current smokers or know history of alcohol or drug abuse.
* History or ongoing severe allergy/hypersensitivity.
* An increased risk for developing SAEs or a contraindication associated with administration of EE, or LNG such as history of thrombosis or thromboembolism, presence of estrogen dependent tumors, hypertension, migraines, and liver disease.
* Participants treated with strong CYP3A4 inhibitors or inducers within 3 months or longer (5 half-lives) prior to first administration of IMP in this study.
* Plasma donation within one month of the Screening Visit or any blood donation/blood loss \> 500 mL during the 3 months prior to the Screening Visit.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longest) of the first administration of IMP in this study.
* Participants who are vegans or have medical dietary restrictions and vulnerable participants.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT06657105
Study Brief:
Protocol Section:
NCT06657105