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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02157467
Eligibility Criteria:
Inclusion Criteria:
1. Signed Written Informed Consent a) The signed informed consent form
2. Target population
* a) Healthy female subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
* b) Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive, at screening and Day -1. BMI = weight (kg)/\[height (m)\]2
* c) Weight greater than or equal to 45 kg
* d) Subject Reenrollment: This study permits the reenrollment of a subject that has discontinued study as a pretreatment failure (ie, has not been treated). If reenrolled, the subject must be reconsented
3. Age and Reproductive Status
* a) Women, 18 to 40 years of age, inclusive
* b) Women of childbearing potential (WOCBP) with intact ovarian function as determined by medical history and history of regular menstrual cycles, and who have been on a stable regimen of Ortho Cyclen for at least 2 consecutive months without evidence of breakthrough bleeding or spotting, or subjects who have been using a stable regimen of another combination oral contraceptive containing EE for at least two months prior to dosing on Day 1 of Cycle 1 and willing to switch to Ortho Cyclen for the total duration of the study (approximately 78 days)
* c) Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to dosing on Day 1 of Cycle 1
* d) Women must not be breastfeeding
Exclusion Criteria:
Medical History and Concurrent Diseases
* a) Any significant acute or chronic medical illness
* b) History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
* c) Current or recent (within 3 months of dosing on Day 1 of Cycle 1) gastrointestinal disease
* d) Any major surgery within 4 weeks of dosing on Day 1 of Cycle 1
* e) Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
* f) Donation of \> 400 mL to a blood bank or in a clinical study (except a screening visit) within 8 weeks of dosing on Day 1 of Cycle 1
* g) Blood transfusion within 4 weeks of dosing on Day 1 of Cycle 1
* h) Inability to tolerate oral medication
* i) Inability to be venipunctured and/or tolerate venous access
* j) Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1 of Cycle 1)
* k) Recent (within 6 months of dosing on Day 1 of Cycle 1) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV), Diagnostic Criteria for Drug and Alcohol Abuse
* l) Any other sound medical, psychiatric, and/or social reason as determined by the investigator
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02157467
Study Brief:
Protocol Section:
NCT02157467