Hepatic Cirrhosis
Conditions
Brief summary
A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)
Interventions
DRUGNRL972
Single intravenous dose of 2 mg NRL972
Sponsors
Norgine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects meeting the following conditions will be eligible for enrolment: General - all subjects 1. Males or females (females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception) 2. Caucasian 3. BMI: between 19 and 34 kg.m-2 4. BW: between 45 and 110 kg 5. willing and able to provide informed consent Healthy volunteers (group N) 6. Age: 18 - 40 years (inclusive) and \> 60 years 7. Assessed as healthy based on the pre-study examination Hepatic cirrhosis 8. Age: 18 - 75 years 9. stable compensated liver cirrhosis (cryptogenic, posthepatic, alcoholic) with histo-logical or macroscopic (e.g. laparascopy, biopsy, ultrasound sonography or other adequate imaging techniques) confirmation
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis | Up to 4 hrs post administration of NRL972 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and changes in physical findings from baseline | Up to 4 hours post-dosing |
| Effects on vital signs: blood pressure, pulse rate | Up to 4 hours post-dosing |
| Effects on electrocardiogram | Up to 4 hours post-dosing |
| Changes in haematology, clinical chemistry, urinalysis | Up to 4 hours post-dosing |
Countries
Bulgaria
Outcome results
None listed