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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT02991261
Eligibility Criteria:
Inclusion Criteria:
1. Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit
2. Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight \>50 kg (110 lbs) at Screening
3. All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit
4. Medically healthy on the basis of medical history and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit.
Exclusion Criteria:
1. Females who are pregnant, lactating, or likely to become pregnant during the study
2. Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder
3. Subjects who need to maintain mental alertness throughout the study
4. Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02991261
Study Brief:
Protocol Section:
NCT02991261