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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT02079233
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteer is ≥ 18 years of age with BMI of 18-32
* Females could not be pregnant or breast feeding and had to be using birth control
* Must have regular bowel habits, typically producing at least 1 daily bowel movement
Exclusion Criteria:
* Screening 12-lead ECG demonstrating QTc interval \>430 msec for males and \>450 msec for females, or any cardiac rhythm disorder considered by the Investigator to be clinically relevant
* History or presence of gastrointestinal conditions
* Positive drug screen for substances of abuse
* Positive results for HIV, hepatitis B, or hepatitis C
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02079233
Study Brief:
Protocol Section:
NCT02079233