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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02859259
Eligibility Criteria:
Inclusion Criteria:
1. Signed Informed Consent
2. Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, vital sign measurements, 12-lead ECG measurements and clinical laboratory test results. Body mass index (BMI) of 18.0 to 32.0 kg/m².
3. Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (i.e., subject has not been randomized/ has not been treated). If re-enrolled, the subject must be re-consented.
4. Age: Males and Females, ages 18 or age of majority to 50 years, inclusive.
5. Reproductive Status: Women of childbearing potential (WOCBP) must have a negative serum/urine (urine test not allowed at screening and Day -1 of Period 1) pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug. Women must not be breastfeeding. Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours). In addition, male subjects must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements. Women of childbearing potential who are continuously not heterosexually active are also exempt from contraceptive requirements, and still undergo pregnancy testing as described in this section.
Exclusion Criteria:
1. Medical History and Concurrent Diseases: History of any chronic or acute illness, gastrointestinal disease, gastrointestinal surgery within less than 4 weeks of dosing, blood donation within 4 weeks of dosing, blood transfusion within 4 weeks of dosing, smoking within less than 12 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. Any other sound medical, psychiatric and/or social reason as determined by the investigator.
2. Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs measurements, ECGs, or clinical laboratory determinations beyond what is consistent with the target population.
3. Exposure to any investigational drug or placebo within 4 weeks of study drug administration.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02859259
Study Brief:
Protocol Section:
NCT02859259