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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00768404
Eligibility Criteria:
Inclusion Criteria:
Group 1 will consist of 8-10 males or females with normal renal function, 19-75 years of age, inclusive.
Groups 2-4 will consist of 8-10 males or females per group with varying degree of stable renal impairment
Exclusion Criteria:
A history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the investigator; any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure; presence of cholelithiasis or cholecystitis within the last 6 months that has not been surgically treated with cholecystectomy; any history of a cardiovascular or cerebrovascular event; subjects requiring dialysis; any active malignancy except basal cell carcinoma; systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 100 mm Hg at screening or at check-in (2 rechecks are allowed); Hemoglobin \<12.0 g/dL for Group 1 (patients with normal renal function); Hemoglobin \<. 9.0 g/dL for Groups 2, 3 and 4 (patients with mild to severe renal function) positive drug/alcohol test at screening or check in; blood donation or significant blood loss within 56 days of dosing; plasma donation within 7 days of dosing. In female subjects, a positive pregnancy test at screening or check-in is exclusionary
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT00768404
Study Brief:
Protocol Section:
NCT00768404