Altered Drug Disposition and Biomarkers for Diagnosis of Chronic Inflammatory Liver Disease
Status and phase
Completed
Phase 1
Conditions
Fatty Liver
Treatments
Other: High fat meal
Drug: Morphine
Study type
Interventional
Funder types
Other
Identifiers
Details and patient eligibility
About
One-third of the U.S. population suffers from non-alcoholic fatty liver disease (NAFLD). NAFLD is caused by diabetes and obesity, and is becoming more common. Although many people have this disease, the change in how the liver handles drugs and compounds in the body has not been studied. The purpose of this study is to investigate how advanced NAFLD changes the ability of the liver to handle both endogenous and exogenous compounds.
Enrollment
22 patients
Sex
All
Ages
18 to 65 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Diagnostic
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
22 participants in 2 patient groups
Healthy volunteers
Experimental group
Description:
Subjects will be asked to fast overnight. Upon presentation, FibroScan procedure with CAP will be conducted and baseline and postprandial bile acid profile will be assessed. Then, intravenous morphine will be administered and the pharmacokinetic profile will be assessed over 8 hours.
Treatment:
Drug: Morphine
Other: High fat meal
Advanced nonalcoholic fatty liver disease patients
Experimental group
Description:
Subjects will be asked to fast overnight. Upon presentation, FibroScan procedure with CAP will be conducted and baseline and postprandial bile acid profile will be assessed. Then, intravenous morphine will be administered and the pharmacokinetic profile will be assessed over 8 hours.
Treatment:
Drug: Morphine
Other: High fat meal
Trial contacts and locations
1
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems