Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT00856869
Status:
COMPLETED
Last Update Posted:
2009-03-06
First Post:
2009-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005234', 'term': 'Fatty Liver'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601594', 'term': 'NRL972'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-05', 'studyFirstSubmitDate': '2009-03-04', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clearance of NRL972 after a standard meal and while fasted in healthy volunteers, patients with NASH and patients with hepatic cirrhosis.', 'timeFrame': 'Up to 4 hours post administration of NRL972'}], 'secondaryOutcomes': [{'measure': 'Adverse events and changes in physical findings from baseline', 'timeFrame': 'Up to 4 hours post-dosing'}, {'measure': 'Effects of vital signs: blood pressure, pulse rate', 'timeFrame': 'Up to 4 hours post-dosing'}, {'measure': 'Effects on electrocardiogram', 'timeFrame': 'Up to 4 hours post-dosing'}, {'measure': 'Changes in haematology, clinical chemistry, urinalysis', 'timeFrame': 'Up to 4 hours post-dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatic Cirrhosis', 'Nonalcoholic Steatohepatitis']}, 'descriptionModule': {'briefSummary': 'The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh \\[CTP\\] class A-C), NASH, young and elderly healthy males, and young and elderly healthy females, to assess the effects of liver dysfunction, gender, age and prandial intestinal hyperaemia on the clearance of NRL972. In addition, the study was to provide information on the safety and tolerability of repeated intravenous doses of NRL972 in these populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nGeneral - all subjects\n\n1. Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)\n2. Caucasian\n3. BMI: between 19 and 34 kg.m-2\n4. BW: between 45 and 110 kg\n5. willing and able to provide informed consent Healthy volunteers (group N)\n6. Age: 18 - 40 years (inclusive) e.g. \\> 60 years\n7. Assessed as healthy based on the pre study examination Hepatic cirrhosis\n8. Age: 18 - 75 years\n9. stable compensated liver cirrhosis (cryptogenic, posthepatic, alcoholic) with histo-logical or macroscopic (e.g. laparascopy, biopsy, ultrasound sonography or other adequate imaging techniques) confirmation Nonalcoholic steatohepatitis (NASH)\n10. Age: 18 - 75 years\n11. Diagnosis of NASH confirmed by liver biopsy\n\nExclusion Criteria:\n\nGeneral - all subjects\n\n1. Previous participation in the trial\n2. Participant in any other trial during the last 90 days\n3. Donation of blood during the last 60 days or a history of blood loss exceeding 450 mL within the last 3 months\n4. History of any clinically relevant allergy\n5. Uncontrolled diabetes mellitus or any further intolerability of the Galactose test\n6. Presence of acute or chronic infection\n7. Resting systolic blood pressure \\> 160 or \\< 90 mmHg, diastolic blood pressure \\> 95 or \\< 50 mmHg\n8. Clinically relevant ECG-abnormalities, prolonged QTc with \\> 450 msec in males and \\> 460 msec in females in particular\n9. Clinically relevant ECG-abnormalities that constitute a contraindication for the Lido-cain-MEG'-X-test\n10. Positive HIV test\n11. Positive alcohol or urine drug test on recruitment\n12. Daily use of \\> 30 gr alcohol\n13. Smoking more than 15 cigarettes/day or equivalent of other tobacco products\n14. Use of prohibited medication\n15. Suspicion or evidence that the subject is not trustworthy and reliable\n16. Suspicion or evidence that the subject is not able to make a free consent or to under-stand the information in this regard\n\n General - all females\n17. Positive pregnancy test\n18. Lactating\n19. Not using appropriate contraception in premenopausal women All healthy subjects\n20. Presence or history of any relevant comorbidity (list of past and present diseases will be reviewed by an expert panel)\n21. Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes, reduced serum creatinine (laboratory test abnormalities will be reviewed by an expert panel)\n22. Positive serology for HBsAg, anti HBc and anti HCV\n23. History of alcohol and/or drug abuse.\n\n Patients with hepatic disease\n24. Biliary liver cirrhosis\n25. Liver impairment due to space-occupying processes (e.g. carcinoma)\n26. State after liver transplantation or patient scheduled for liver transplantation\n27. Fluctuating or rapidly deteriorating hepatic function\n28. Significant bleeding diathesis\n29. Oesophageal bleeding within the last 8 weeks before study entry\n30. Ascites \\> 6 L on abdominal US\n31. Number Connection test: time to connect 25 consecutive numbers \\> 30 sec\n32. Presence or history of any relevant comorbidity other than hepatic disease (list of past and present diseases will be reviewed by an expert panel)\n33. Clinically relevant abnormal laboratory values other than those associated or sufficiently explained by the existing liver disease (laboratory test abnormalities will be reviewed by an expert panel)\n34. History of drug or alcohol abuse within 2 months prior to dosing"}, 'identificationModule': {'nctId': 'NCT00856869', 'briefTitle': 'Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Norgine'}, 'officialTitle': 'A Study in Healthy Volunteers and Patients With Liver Cirrhosis and Non-Alcoholic Steatohepatitis (NASH) to Assess the Effects of Age, Gender, Chronic Liver Disease, and Prandial Effects on the Clearance of Cholyl-Lysyl-Fluorescein (NRL972) an an in-Vivo Marker of Liver Function in Man.', 'orgStudyIdInfo': {'id': 'NRL972-02/2003(ACPS)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 YM', 'description': 'Healthy young males', 'interventionNames': ['Drug: NRL972']}, {'type': 'EXPERIMENTAL', 'label': '2 EM', 'description': 'Healthy elderly males', 'interventionNames': ['Drug: NRL972']}, {'type': 'EXPERIMENTAL', 'label': '3 YF', 'description': 'Healthy young females', 'interventionNames': ['Drug: NRL972']}, {'type': 'EXPERIMENTAL', 'label': '4 EF', 'description': 'Healthy elderly females', 'interventionNames': ['Drug: NRL972']}, {'type': 'EXPERIMENTAL', 'label': '5 NASH', 'description': 'Patients with presumed NASH', 'interventionNames': ['Drug: NRL972']}, {'type': 'EXPERIMENTAL', 'label': '6 CTP-A', 'description': 'Patients with hepatic cirrhosis CTP-class A', 'interventionNames': ['Drug: NRL972']}, {'type': 'EXPERIMENTAL', 'label': '7 CTP-BC', 'description': 'Patients with hepatic cirrhosis CTP-class B and C', 'interventionNames': ['Drug: NRL972']}], 'interventions': [{'name': 'NRL972', 'type': 'DRUG', 'description': 'Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal', 'armGroupLabels': ['1 YM']}, {'name': 'NRL972', 'type': 'DRUG', 'description': 'Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal', 'armGroupLabels': ['2 EM']}, {'name': 'NRL972', 'type': 'DRUG', 'description': 'Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal', 'armGroupLabels': ['3 YF']}, {'name': 'NRL972', 'type': 'DRUG', 'description': 'Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal', 'armGroupLabels': ['4 EF']}, {'name': 'NRL972', 'type': 'DRUG', 'description': 'Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal', 'armGroupLabels': ['5 NASH']}, {'name': 'NRL972', 'type': 'DRUG', 'description': 'Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal', 'armGroupLabels': ['6 CTP-A']}, {'name': 'NRL972', 'type': 'DRUG', 'description': 'Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal', 'armGroupLabels': ['7 CTP-BC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': "UMHAPT St. Ivan Rilski's University Hospital", 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'overallOfficials': [{'name': 'Zahariy Krastev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Ivan Rilski's University Hospital"}, {'name': 'Hans-Jürgen Gruss, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norgine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norgine', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Vice President Clinical Development', 'oldOrganization': 'Norgine'}}}}