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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT02467335
Eligibility Criteria:
Inclusion Criteria:
* Males and females, ages 18 to 70 years, inclusive
* BMI: 18.5 to 38 kg/m2
* Body weight great or equal to 45.5 kg
* Subjects with hepatic impairment
* Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
* Healthy subjects to the extent possible matched to the first four subjects with hepatic impairment with regard to age, body weight, and sex, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria:
* Any major surgery within 4 weeks of study drug administration
* Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
* Subject has required additional medication for hepatic encephalopathy within 12 months (6 months for severe hepatic impairment) prior to dosing
* Presence of severe ascites or edema in subjects, as judged by the PI
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02467335
Study Brief:
Protocol Section:
NCT02467335