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Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00856713
First received: March 4, 2009
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

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)


Condition Intervention Phase
Hepatic Cirrhosis
Drug: NRL972
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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) as an in-Vivo Marker of Liver Function in Man

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis [ Time Frame: Up to 4 hrs post administration of NRL972 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events and changes in physical findings from baseline [ Time Frame: Up to 4 hours post-dosing ] [ Designated as safety issue: Yes ]
  • Effects on vital signs: blood pressure, pulse rate [ Time Frame: Up to 4 hours post-dosing ] [ Designated as safety issue: Yes ]
  • Effects on electrocardiogram [ Time Frame: Up to 4 hours post-dosing ] [ Designated as safety issue: Yes ]
  • Changes in haematology, clinical chemistry, urinalysis [ Time Frame: Up to 4 hours post-dosing ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: March 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 YM
Healthy young males
Drug: NRL972
Single intravenous dose of 2 mg NRL972
Experimental: 2 EM
Healthy elderly males
Drug: NRL972
Single intravenous dose of 2 mg NRL972
Experimental: 3 YF
Healthy young females
Drug: NRL972
Single intravenous dose of 2 mg NRL972
Experimental: 4 EF
Healthy elderly females
Drug: NRL972
Single intravenous dose of 2 mg NRL972
Experimental: 5 CTP-A
Patients with hepatic cirrhosis CTP-class A
Drug: NRL972
Single intravenous dose of 2 mg NRL972
Experimental: 6 CTP-BC
Patients with hepatic cirrhosis CTP-class B and C
Drug: NRL972
Single intravenous dose of 2 mg NRL972

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856713

Locations
Bulgaria
UMHAPT St Ivan Rilski's University Hospital
Sofia, Bulgaria, 1431
Sponsors and Collaborators
Norgine
Investigators
Study Director: Hans-Jürgen Gruss, MD Norgine
Principal Investigator: Zahariy Krastev, MD St Ivan Rilski's University Hospital
  More Information

No publications provided

Responsible Party: Vice President Clinical Development, Norgine
ClinicalTrials.gov Identifier: NCT00856713     History of Changes
Other Study ID Numbers: NRL972-01/2005 (ACPS)
Study First Received: March 4, 2009
Last Updated: March 5, 2009
Health Authority: Bulgaria: Ministry of Health

Additional relevant MeSH terms:
Liver Cirrhosis
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on November 20, 2014