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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT01431833
Eligibility Criteria:
Inclusion Criteria:
* Moderate or severe hepatic impairment or matched control
* BMI between 18.0 and 40.0 kg/m2
Exclusion Criteria:
* Evidence of acute deterioration of hepatic function within 8 weeks
* ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper limit of normal for severes
* Total bilirubin \> 5 mg/dl for moderates; no upper limit for severes
* Hemoglobin \< 10g/dl for moderates; Hemoglobin \< 9g/dl for severes
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01431833
Study Brief:
Protocol Section:
NCT01431833