NCT00856869

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
Last Updated

March 6, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

March 4, 2009

Last Update Submit

March 5, 2009

Conditions

Hepatic CirrhosisNonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

  • Clearance of NRL972 after a standard meal and while fasted in healthy volunteers, patients with NASH and patients with hepatic cirrhosis.

    Up to 4 hours post administration of NRL972

Secondary Outcomes (4)

  • Adverse events and changes in physical findings from baseline

    Up to 4 hours post-dosing

  • Effects of vital signs: blood pressure, pulse rate

    Up to 4 hours post-dosing

  • Effects on electrocardiogram

    Up to 4 hours post-dosing

  • Changes in haematology, clinical chemistry, urinalysis

    Up to 4 hours post-dosing

Study Arms (7)

1 YM

EXPERIMENTAL

Healthy young males

Drug: NRL972

2 EM

EXPERIMENTAL

Healthy elderly males

Drug: NRL972

3 YF

EXPERIMENTAL

Healthy young females

Drug: NRL972

4 EF

EXPERIMENTAL

Healthy elderly females

Drug: NRL972

5 NASH

EXPERIMENTAL

Patients with presumed NASH

Drug: NRL972

6 CTP-A

EXPERIMENTAL

Patients with hepatic cirrhosis CTP-class A

Drug: NRL972

7 CTP-BC

EXPERIMENTAL

Patients with hepatic cirrhosis CTP-class B and C

Drug: NRL972

Interventions

NRL972DRUG

Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal

1 YM

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • General - all subjects
  • Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
  • Caucasian
  • BMI: between 19 and 34 kg.m-2
  • BW: between 45 and 110 kg
  • willing and able to provide informed consent Healthy volunteers (group N)
  • Age: 18 - 40 years (inclusive) e.g. \> 60 years
  • Assessed as healthy based on the pre study examination Hepatic cirrhosis
  • Age: 18 - 75 years
  • 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)
  • Age: 18 - 75 years
  • Diagnosis of NASH confirmed by liver biopsy

You may not qualify if:

  • General - all subjects
  • Previous participation in the trial
  • Participant in any other trial during the last 90 days
  • Donation of blood during the last 60 days or a history of blood loss exceeding 450 mL within the last 3 months
  • History of any clinically relevant allergy
  • Uncontrolled diabetes mellitus or any further intolerability of the Galactose test
  • Presence of acute or chronic infection
  • Resting systolic blood pressure \> 160 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
  • Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
  • Clinically relevant ECG-abnormalities that constitute a contraindication for the Lido-cain-MEG'-X-test
  • Positive HIV test
  • Positive alcohol or urine drug test on recruitment
  • Daily use of \> 30 gr alcohol
  • Smoking more than 15 cigarettes/day or equivalent of other tobacco products
  • Use of prohibited medication
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMHAPT St. Ivan Rilski's University Hospital

Sofia, 1431, Bulgaria

Location

MeSH Terms

Conditions

Liver CirrhosisNon-alcoholic Fatty Liver Disease

Interventions

NRL972

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsFatty Liver

Study Officials

  • Zahariy Krastev, MD

    St. Ivan Rilski's University Hospital

    PRINCIPAL INVESTIGATOR

  • Hans-Jürgen Gruss, MD

    Norgine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

August 1, 2004

Primary Completion

February 1, 2005

Study Completion

April 1, 2005

Last Updated

March 6, 2009

Record last verified: 2009-03

Locations

BU(1)