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 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT01356550
Eligibility Criteria:
Inclusion Criteria:
General:
* Body mass index (BMI) between 18 and 32 kg/m2 inclusive
Healthy Subjects:
* Adult male or female subjects, 18-70 years of age
Hepatically impaired patients:
* Adult patients, 18-65 years of age
* Documented chronic stable mild/moderate/severe liver disease (Child-Pugh class A, B or C)
* Hepatic impairment should be primary and must not be a complication of an underlying primary disease
Exclusion Criteria:
General:
* Pregnant or lactating women
* Suspicion of drug abuse or addiction at time of screening/Day -1 or history of drug abuse in the last month (patients) or last year (healthy volunteers) prior to Day -1
* Confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
* Positive for HIV infection
* Renal insufficiency
Healthy volunteers:
* History of significant disease, or evidence of disease or condition which could interfere with the study or relapse during or immediately after the study
* Any history of depressive episodes or treatment with antidepressants
* Alcohol consumption averaging more than 2 units (16 g) of alcohol for females or 3 units (24 g) for males per day, or positive alcohol breath test at screening/Day -1
* Positive for hepatitis B and/or hepatitis C infection
Hepatically impaired patients:
* Evidence of unstable clinically significant disease other than impaired hepatic function, or condition or disease which could interfere with the study or relapse during or immediately after the study
* Episode of acute depression within the last 6 months or current or previous (within the last 6 months) antidepressant treatment
* Hepatocellular carcinoma or acute hepatic disease caused by infection or drug toxicity
* Presence of surgically created or transjugular intrahepatic portal systemic shunts
* Biliary liver cirrhosis or other causes of hepatic impairment not related to parenchyma disorder and/or disease of the liver
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01356550
Study Brief:
Protocol Section:
NCT01356550