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 @ 6:39 PM
Ignite Modification Date:
2025-12-24 @ 6:39 PM
NCT ID:
NCT01419457
Eligibility Criteria:
Inclusion Criteria:
* Hepatically impaired groups:
* Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.
* Have mild hepatic impairment (Child-Pugh Clinical Assessment Score Grade A, score 5 6) or moderate hepatic impairment (Child-Pugh Clinical Assessment Score Grade B, score 7-9) or severe hepatic impairment (Child-Pugh Clinical Assessment Score Grade C, score 10-15);
* Control group
* Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.
* Healthy as determined by medical history, physical exam, vital signs, ECGs, and clinical laboratory tests.
Exclusion Criteria:
* Hepatically impaired groups:
* Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;
* Have any acute or unstable condition or disease, other than impaired hepatic function, as determined by medical history, physical exam, ECG and clinical laboratory tests;
* Known ongoing alcohol and/or drug abuse within 1 month
* Any evidence of progressive worsening liver function disease as indicated by laboratory values;
* Have had an acute flare of hepatitis A or B within 6 months;
* Have acute, fulminant alcoholic hepatitis, determined either clinically or by histology;
* Have a history of hepatoma or metastatic disease of the liver;
* Control group:
* Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;
* Have a history or presence of clinically cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, psychiatric, pulmonary, or renal disease or any other condition.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
69 Years
Study:
NCT01419457
Study Brief:
Protocol Section:
NCT01419457