Effect of Non-Alcoholic Steatohepatitis (NASH) on the Pharmacokinetics of 99mTechnetium-Mebrofenin

Completed · Phase 1

Conditions studied: Non-alcoholic Steatohepatitis

In brief

This study is designed to investigate the effect of NASH (non-alcoholic steatohepatitis) on the disposition of 99mTechnetium(Tc)-mebrofenin and to relate changes in 99mTc-mebrofenin disposition to differences in the bile acid profile and Fibroscan Fibrosis Score of healthy subjects compared to patients with NASH.

Key facts

Study ID

NCT02235233

Run by

University of North Carolina, Chapel Hill

People needed

21

Starts

2015-04-01

Expected to finish

2016-07-01

Last updated by the study team

2017-05-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy subjects: defined as being free from significant cardiac, pulmonary, gastrointestinal, hepatic, biliary, renal, hematological, neurological and psychiatric disease as determined by history, physical examination and clinical laboratory test results.
• NASH subjects only: defined as those who have had a recent liver biopsy consistent with NASH without cirrhosis; NAS score >3.
• Fluent and literate in English.
• Willing and able to give informed consent prior to entering the study.

You may not qualify if…

• Donation of blood within last 30 days.
• History of significant alcohol abuse (>20g/day) and/or illicit drug use, whether successfully treated or not.
• Inability to abstain from alcohol for 48 hours prior to study visits.
• Inability to fast for 8 hours prior to study sample collection.
• Women who are pregnant, trying to become pregnant, or breast feeding.
• 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.
• Serum blood glucose reading at study enrollment of >200 mg/dL.
• 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. A multivitamin and vitamin E at standard doses will be allowed.
• Previous liver biopsy that demonstrated presence of cirrhosis.
• Radiologic imaging consistent with cirrhosis or portal hypertension.
• Evidence of decompensated liver disease defined as any of the following: serum albumin <3.2 g/dL, total bilirubin > 1.5 mg/dL, or PT/INR > 1.3 times normal at screening, or history or presence of ascites, encephalopathy, or bleeding from esophageal varices.
• 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).
• Primary, secondary or extrahepatic malignancy.
• History of bariatric surgery.
• Participation in a research drug trial, exclusive of the SyNCH Phase I or II trials, within 30 days of screening.
• BMI > 45 kg/m2 at screening (body weight is not within 20% of ideal body weight).
• Inability or unwillingness to give informed consent or abide by the study protocol.
• Estimated weekly strenuous exercise greater than 4 hours per week.
• History or other evidence of illness or any other conditions or drug therapies that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, coronary artery disease, active gastrointestinal conditions or taking drugs known to interfere with bile acid synthesis or metabolism or the metabolism/transport of other drugs).
• Undergone a radiographic procedure (other than dental X-rays), received radioactive substances, or handled radioactive materials in conjunction with employment within the last twelve months.
• A history of hypersensitivity to 99mTc-mebrofenin, ultrasound gel, dairy products, or their excipients.
• Consumed caffeine (coffee, tea, colas, and chocolate) within 24 hours of the study.

Where it is running

• UNC Hospitals — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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