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.
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 after a 15-second intravenous (i.v.) injection of 2 mg NRL972 against the diagnostic assessment based on liver biopsy in patients with clinically suspected NAFLD. A particular focus was to separate simple fatty liver disease (non-NASH) from non-alcoholic steatohepatitis (NASH) with or without cirrhosis (defined as advanced fibrosis: ≥F3) in a population likely to present with NAFLD. The study evaluated the predictive value of NRL972 pharmacokinetics in the diagnosis of NASH using fatty liver disease (non-NASH) as the comparator group in a population of clinically suspected NAFLD patients based on histological evaluation. The sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic was compared to that of results from the standard laboratory tests, clinical features, elastography assessments for liver stiffness and tests of metabolic markers, serum fibrosis markers and established disease scores frequently used in the evaluation of NAFLD. The study also provided information on the safety and tolerability of i.v. doses of NRL972 under these conditions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
125
Single dose of 2 mg NRL972 administered intravenously. Total volume 5mL.
Duke University Medical Center
Durham, North Carolina, United States
C(30)/C(10)
The primary efficacy variable was 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
Adverse Events
Primary safety assessment: Incidence of treatment-emergent adverse events
Time frame: Up to 2 hours post-dose
Vital Signs
Primary safety assessment: continuous monitoring on automated cardiovascular systems
Time frame: Up to 2 hours post-dose
C(60)
NRL972 fractional retention ratio for 60 minutes post-dose for different populations with NAFLD.
Time frame: 60 minutes post-dose
t1/2
apparent terminal disposition half-life
Time frame: 60 minutes post-dose
CL
approximate overall clearance
Time frame: 60 minutes post-dose
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