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

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