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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT00547560
Eligibility Criteria:
Inclusion Criteria:
* Men or women, greater than or equal to 65 years of age.
* Women of nonchildbearing potential (WONCP) may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with FSH greater than or equal to 38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
* Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight \>50 kg.
Exclusion Criteria:
n/a
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00547560
Study Brief:
Protocol Section:
NCT00547560