NCT lookup

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.

• Brooklyn, Maryland, United States