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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01856556
Eligibility Criteria:
Inclusion Criteria:
1. Male and female subjects
2. Aged 18 to 55 years
3. For female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control from date of screening to at least 30 days after the last dose of study drugIf of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.
4. Clinical laboratory values less than or equal to 2 times the upper limit of normal (ULN) or deemed not clinically significant by the Investigator.
5. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
Exclusion Criteria:
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01856556
Study Brief:
Protocol Section:
NCT01856556