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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT00769418
Eligibility Criteria:
Inclusion Criteria:
* Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age
* Females must be past menopause
* Subject is a nonsmoker
* Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling
* Subject is willing to refrain from consuming grapefruit or grapefruit juice
Exclusion Criteria:
* Subject has a history of multiple/severe allergies to drugs or food
* Subject has donated blood within 4 weeks of starting the study
* Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment
* Subject has any infections or any condition leading to immune problems, including HIV
* Subject regularly uses illegal drugs
* Subject consumes more than 3 alcoholic beverages per day
* Subject drinks 4 or more caffeinated beverages per day
* Subject uses any prescription or nonprescription medications
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00769418
Study Brief:
Protocol Section:
NCT00769418