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

NCT00794716 | Completed Phase 2 FDA Drug

• 1 other identifier: NRL972-01/2007 (FLD)
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (3)

• 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.

  30 minutes post-dose

• Adverse Events

  Primary safety assessment: Incidence of treatment-emergent adverse events

  Up to 2 hours post-dose

• Vital Signs

  Primary safety assessment: continuous monitoring on automated cardiovascular systems

  Up to 2 hours post-dose

Secondary Outcomes (3)

• C(60)

  60 minutes post-dose

• t1/2

  60 minutes post-dose

• CL

  60 minutes post-dose

Study Arms (1)

NRL972

EXPERIMENTAL

2 mg NRL972 IV

Drug: NRL972

Interventions

NRL972 DRUG

Single dose of 2 mg NRL972 administered intravenously. Total volume 5mL.

Also known as: cholyl-lysyl-fluorescein

NRL972

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Glass O, Henao R, Patel K, Guy CD, Gruss HJ, Syn WK, Moylan CA, Streilein R, Hall R, Mae Diehl A, Abdelmalek MF. Serum Interleukin-8, Osteopontin, and Monocyte Chemoattractant Protein 1 Are Associated With Hepatic Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Hepatol Commun. 2018 Sep 21;2(11):1344-1355. doi: 10.1002/hep4.1237. eCollection 2018 Nov.

  PMID: 30411081 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

NRL972

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Manal F Abdelmalek, M.D., MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 20, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: November 1, 2011
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)