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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT01161069
Eligibility Criteria:
Inclusion Criteria:
* Healthy persons, male or female.
* For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive.
* For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive.
* Body Mass Index (BMI) of 18 to 35; and a total body weight \>50 kg (110 lbs)
Exclusion Criteria:
* Subjects with clinically significant medical conditions.
* Women of non-child bearing potential.
* Subjects with a known medical history of hearing loss/disability or nonarteritic ischemic optic neuropathy.
* A positive urine drug screen.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01161069
Study Brief:
Protocol Section:
NCT01161069