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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT00382668
Eligibility Criteria:
Inclusion Criteria - All subjects:
* Male and females ≥18 years old
* Women must be of non-childbearing potential
* Adequate hematologic and renal function
* BMI 18-35 kg/m2
Inclusion Criteria - Liver Impaired subjects:
* Subjects must have stable liver impairment diagnosed with standard classification - Child Pugh
Exclusion Criteria - All subjects:
* Inability to swallow or absorb oral medication
* Uncontrolled medical disorder or infection
* Use of CYP3A4 inhibitors/inducers or drugs with risk of Torsades de Pointes
* Uncontrolled or Significant cardiovascular disease
* Any significant bleeding disorder
* Female subjects of childbearing potential
* Male subjects unwilling to use an effective method of contraception throughout the conduct of the study and for 2 months thereafter
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00382668
Study Brief:
Protocol Section:
NCT00382668