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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT01888393
Eligibility Criteria:
Inclusion Criteria:
Group A: Subjects with Moderate Hepatic Impairment
* Male and female 18 to 65 years of age (inclusive)
* Satisfy the criteria for moderate hepatic impairment defined as a Child Pugh total score of 7 to 9 (Child Pugh Class B) at the Screening Visit
* Willing and able to comply with schedule visits, treatment, laboratory tests, and contraceptive guidelines.
Group B: Healthy subjects
* Male and female 18 to 65 years of age (inclusive)
* Healthy subjects with no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG, and clinical laboratory tests
* Willing and able to comply with schedule visits, treatment, laboratory tests, contraceptive guidelines and other study procedures
Exclusion Criteria:
Group A: Subjects with Moderate Hepatic Impairment
* History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* Have fluctuating or rapidly deteriorating hepatic function by history or as indicated by significant variations in or worsening of clinical and/or laboratory signs of hepatic impairment within 6 months before the Screening Visit
* Other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver
* Severe hepatic encephalopathy
* Type 1 diabetes mellitus or evidence of poorly controlled type 2 diabetes
* Hepatocellular carcinoma, HIV, hepatitis B/C
* Significant renal dysfunction
* Solid organ or bone marrow transplantation
* History of regular alcohol consumption, drug abuse or regular smoking
Group B: Healthy subjects
* History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* History of regular alcohol consumption, drug abuse or regular smoking
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01888393
Study Brief:
Protocol Section:
NCT01888393