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Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers

Primary Purpose

Hepatic Cirrhosis

Status

Completed

Phase

Phase 1

Locations

Bulgaria

Study Type

Interventional

Intervention

NRL972

About this trial

This is an interventional diagnostic trial for Hepatic Cirrhosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects meeting the following conditions will be eligible for enrolment:

General - all subjects

Males or females (females of non-child-bearing potential or of child-bearing 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) and > 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

Exclusion Criteria:

Subjects of any of the following categories will be excluded from enrolment:

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 300 mL within the last 3 months
History of any clinically relevant allergy
Presence of acute or chronic infection
Uncontrolled diabetes mellitus
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
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
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 under-stand the information in this regard
General - all females
Positive pregnancy test
Lactating
Not using appropriate contraception in premenopausal women
All healthy subjects
Presence or history of any relevant comorbidity
Presence of any relevant abnormality in the laboratory safety tests, especially low Hemoglobin, increased liver enzymes, reduced serum creatinine
Positive serology for HBsAg, anti HBc and anti HCV
History of alcohol and/or drug abuse
Patients with hepatic disease
Biliary liver cirrhosis
Liver impairment due to space-occupying processes (e.g. carcinoma)
State after liver transplantation or patient scheduled for liver transplantation

Sites / Locations

UMHAPT St Ivan Rilski's University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

1 YM

2 EM

3 YF

4 EF

5 CTP-A

6 CTP-BC

Arm Description

Healthy young males

Healthy elderly males

Healthy young females

Healthy elderly females

Patients with hepatic cirrhosis CTP-class A

Patients with hepatic cirrhosis CTP-class B and C

Outcomes

Primary Outcome Measures

Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis

Secondary Outcome Measures

Adverse events and changes in physical findings from baseline

Effects on vital signs: blood pressure, pulse rate

Effects on electrocardiogram

Changes in haematology, clinical chemistry, urinalysis

Full Information

NCT ID

NCT00856713

First Posted

March 4, 2009

Last Updated

March 5, 2009

Sponsor

Norgine

1. Study Identification

Unique Protocol Identification Number

NCT00856713

Brief Title

Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Norgine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Cirrhosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 YM

Arm Type

Experimental

Arm Description

Healthy young males

Arm Title

2 EM

Arm Type

Experimental

Arm Description

Healthy elderly males

Arm Title

3 YF

Arm Type

Experimental

Arm Description

Healthy young females

Arm Title

4 EF

Arm Type

Experimental

Arm Description

Healthy elderly females

Arm Title

5 CTP-A

Arm Type

Experimental

Arm Description

Patients with hepatic cirrhosis CTP-class A

Arm Title

6 CTP-BC

Arm Type

Experimental

Arm Description

Patients with hepatic cirrhosis CTP-class B and C

Intervention Type

Drug

Intervention Name(s)

NRL972

Intervention Description