Pharmacokinetics of NRL972 in Patients With Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)

This is an interventional diagnostic trial for Non-Alcoholic Fatty Liver Disease Read More

Inclusion Criteria:

Subjects meeting the following conditions will be eligible for enrollment:

• Males or females (females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
• Any ethnicity
• Age: 18 to 80 years of age
• Clinical evidence of non-alcoholic liver disease requiring the conduct of a liver biopsy for the diagnosis of NAFLD and/or staging of disease severity
• Willing and able to provide informed consent

Exclusion Criteria:

Subjects fulfilling any of the following criteria will be excluded from enrollment:

General - all subjects

• Presence of acute or chronic viral hepatitis confirmed by serology
• Clinical signs of significant cholestasis
• Liver impairment due to space-occupying processes (e.g. carcinoma)
• Liver transplant recipient or patient scheduled for liver transplantation
• Clinically evident rapidly deteriorating hepatic function
• Significant bleeding diathesis
• Esophageal bleeding within the 8 weeks prior to study entry
• Presence of any contraindications for the conduct of the planned liver biopsy (e.g. allergy to lidocaine, coagulopathy with <100 x109/L thrombocytes and/or INR >1.3
• History of any allergic reaction to fluorescein
• Presence of any acute infection
• Previous participation in this trial
• Having received any investigational drug or treatment within 30 days prior to study entry or requiring a concurrent treatment with any other experimental drug or treatment
• Uncontrolled hypo- or hypertension (treated or untreated) with resting systolic blood pressure >160 or < 90 mmHg, diastolic blood pressure >95 or < 50 mmHg
• Clinically relevant abnormal laboratory values indicating end-stage renal, pulmonary or cardiac disease
• Known HIV infection
• Concurrent alcohol use of more than 14 drinks (140g ethanol) for men and 7 drinks (70g ethanol) for women per week (each drink is counted as 10g ethanol)
• History of drug or alcohol abuse within 2 months prior to dosing
• Use of prohibited medication (section 4.8)
• Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
• Suspicion or evidence that the subject is not trustworthy and reliable
• Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard
• Significant side effects prior to the liver biopsy (e.g. anxiety requiring pre-medication) or after the biopsy (e.g. pain requiring i.v. pain medication, bleeding re-quiring medical intervention)

General - all females

• Positive pregnancy test
• Pre-menopausal women not using appropriate contraception