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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT01766960
Eligibility Criteria:
Inclusion Criteria:
General:
* Man or woman between 18 and 65 years of age
* Negative pregnancy test for women of childbearing potential
* Negative urine drug screen
Healthy Subjects:
* Normal liver function tests
* Normal kidney function and lipid panel
Nonalcoholic Steatohepatitis Patients:
* Recent liver biopsy with nonalcoholic fatty liver disease activity score at least 4
Exclusion Criteria:
General:
* History of significant alcohol use (\>20 g/day) and/or illicit drug use
* Inability to abstain from alcohol for 48 prior to study
* Use of drugs associated with a clinical or histological picture consistent with fatty liver disease or NASH for more than 12 consecutive weeks in the year prior to screening; these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens (at doses greater than those used for hormone replacement) or valproate/valproic acid
* Type 2 diabetes treated with oral agents other than metformin; these include secretagogues, thiazolidinediones, alpha-glucosidase inhibitors, exenatide and pramlintide.
* Current or recent use of bile acid sequestrants, bile acid derivatives (i.e. ursodiol) or fibric acid derivatives.
* Current use of antioxidants such as silymarin, vitamin C, glutathione, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations, and special teas) within 30 days prior to screening.
* Previous liver biopsy that demonstrated presence of cirrhosis.
* Radiologic imaging consistent with cirrhosis or portal hypertension.
* Serum creatinine of 2.0 mg/dL or greater, or on dialysis, at screening.
* History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis) that could affect the assessment of biomarkers (bile acids or inflammation).
* History of bariatric surgery.
* BMI \> 45 kg/m\^2 at screening.
* Any known hypersensitivity to opiates, opiate antagonists, or ondansetron.
Healthy Subjects:
* Taking concomitant medications, both prescription and non-prescription (including herbal products and over-the-counter medications), other than oral contraceptives and multivitamins (women stabilized on hormonal methods of birth control will be allowed to participate)
* History or other evidence of liver disease in the opinion of the study investigators.
* BMI \> 30 kg/m\^2 at screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01766960
Study Brief:
Protocol Section:
NCT01766960