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 @ 12:50 PM
Ignite Modification Date:
2025-12-24 @ 12:50 PM
NCT ID:
NCT02475161
Eligibility Criteria:
Inclusion Criteria:
* If a woman, must be postmenopausal (no spontaneous menses for at least 2 years) or surgically sterile (including but not limited to hysterectomy, oophorectomy, salpingectomy, tubal ligation, and tubal occlusion). Women must agree to not donate eggs (ova, oocytes) during the study and for 3 months after the last dose of study drug. Women of child-bearing potential or currently breastfeeding a child are not allowed to participate in the study
* If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
* Body mass index (BMI) (weight \[kilogram {kg}/height\^2 \[meter\]\^2) between 18 and 30 kg/m\^2 (inclusive), and body weight not less than 50 kg
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
* A participants must be a non-smoker
Exclusion Criteria:
* Current or history of gastrointestinal disorder
* Clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic disease, infection, hypertension or vascular disorders, kidney or urinary tract disturbances, significant psychiatric disorder (history of or current diagnosis), history of epilepsy or fits of unexplained black-outs, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, or thyroid stimulating hormone (TSH) at screening or at admission to the study center (Day -1) as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at admission to the study center (Day -1) as deemed appropriate by the investigator
* Use of any prescription or nonprescription medication, within 7 days before the first scheduled dose of the study drug (including vitamins and herbal supplements), except acetaminophen and hormonal replacement therapy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02475161
Study Brief:
Protocol Section:
NCT02475161