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:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT02621957
Eligibility Criteria:
Inclusion Criteria:
* Female subjects between 18 and 65 years of age, inclusive.
* Female subjects of non-childbearing potential including non-pregnant, non-lactating, and either postmenopausal or surgically sterile for at least 45 days post procedure.
* Within BMI range 18.5 to \</= 29.9 kg/m\^2, inclusive.
* In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations.
* Receive an explanation of the mandatory pharmacogenomic (PgX) component of the study.
Exclusion Criteria:
* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder.
* Previous history of adverse reaction to statins.
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1) in Period 1.
* Use of systemic hormone replacement therapy within 1 year prior to Check-in (Day -1).
* History of use of tamoxifen, aromatase inhibitor or any other endocrine agent for treatment of breast cancer.
* Female subject is pregnant lactating, or breast feeding.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02621957
Study Brief:
Protocol Section:
NCT02621957