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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT02255968
Eligibility Criteria:
Key Inclusion Criteria:
* In good general health
* BMI between 18 - 32 kg/m2
* Women must be of non-childbearing potential (surgically sterilized)
* Normal electrocardiogram
* Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 17 - 19 day post-dosing visit
Key Exclusion Criteria:
* Hypersensitivity to macrolide antibiotics
* Abnormal laboratory values
* Gastroenteritis within 1 week of study drug administration
* Use of any investigational drugs within 28 days of study drug administration
* History of gastrointestinal surgery which may interfere with drug absorption
* Active Hepatitis B, Hepatitis C, or HIV infection
* Use of prescription or non-prescription drugs within 14 days of study drug administration
* Use of nicotine within 3 months of study drug administration
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02255968
Study Brief:
Protocol Section:
NCT02255968