Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers

Exclusion Criteria

• •Subjects of any of the following categories will be excluded from enrolment:
• •General - all subjects
• •1. Previous participation in the trial
• •2. Participant in any other trial during the last 90 days
• •3. Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
• •4. History of any clinically relevant allergy
• •5. Presence of acute or chronic infection
• •6. Uncontrolled diabetes mellitus
• •7. Resting systolic blood pressure \> 160 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
• •8. Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
• •9. Positive HIV test
• •10. Positive alcohol or urine drug test on recruitment
• •11. Daily use of \> 30 gr alcohol
• •12. Smoking more than 15 cigarettes/day or equivalent of other tobacco products
• •13. Use of prohibited medication
• •14. Suspicion or evidence that the subject is not trustworthy and reliable
• •15. Suspicion or evidence that the subject is not able to make a free consent or to under-stand the information in this regard
• •General - all females
• •16. Positive pregnancy test
• •17. Lactating
• •18. Not using appropriate contraception in premenopausal women
• •All healthy subjects
• •19. Presence or history of any relevant comorbidity
• •20. Presence of any relevant abnormality in the laboratory safety tests, especially low Hemoglobin, increased liver enzymes, reduced serum creatinine
• •21. Positive serology for HBsAg, anti HBc and anti HCV
• •22. History of alcohol and/or drug abuse
• •Patients with hepatic disease
• •23. Biliary liver cirrhosis
• •24. Liver impairment due to space-occupying processes (e.g. carcinoma)
• •25. State after liver transplantation or patient scheduled for liver transplantation