Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00794716
First received: November 19, 2008
Last updated: August 6, 2010
Last verified: August 2010
  Purpose

This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of steatohepatitis using fatty liver disease as the comparator group. In addition, the sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared to results from the standard laboratory tests, elastography, tests of metabolic markers and serum fibrosis markers frequently used in the evaluation of clinically predicted NAFLD patients. Patients will be included if they have clinical evidence of fatty liver disease and have been referred to the clinic for a diagnostic work-up, including a liver biopsy, blood tests and scans of the liver.


Condition Intervention Phase
Non-Alcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Other: NRL972
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Single-centre, Open-label Study to Assess the Pharmacokinetics of Cholyl-lysl-fluorescein (NRL972) in Patients With Clinical Evidence for Non-alcoholic Fatty Liver Disease (NAFLD): Supporting the Disease Staging Into Fatty Liver Disease Versus Non-alcoholic Steatohepatitis (NASH)

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • The primary efficacy variable is the NRL972 fractional retention ratio for 10 and 30 minutes post-dose (C30/C10) for different populations with NAFLD. [ Time Frame: 30 minutes post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Approximate overall clearance and t½ within 60 minutes of dosing with NRL972. Cmax, AUC(0-∞), and mean residence time derived from a non-compartmental analysis. [ Time Frame: 60 minutes post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: June 2008
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: NRL972
    Single dose of 2 mg NRL972 administered intravenously. Total volume 5mL.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects meeting the following conditions will be eligible for enrollment:

  • Males or females (females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
  • Any ethnicity
  • Age: 18 to 80 years of age
  • Clinical evidence of non-alcoholic liver disease requiring the conduct of a liver biopsy for the diagnosis of NAFLD and/or staging of disease severity
  • Willing and able to provide informed consent

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
  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: NCT00794716

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: Manal F Abdelmalek, M.D., MPH Duke University
  More Information

No publications provided

Responsible Party: Vice President, Clinical Development, Norgine Ltd
ClinicalTrials.gov Identifier: NCT00794716     History of Changes
Other Study ID Numbers: NRL972-01/2007 (FLD)
Study First Received: November 19, 2008
Last Updated: August 6, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014