Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Hepatic Cirrhosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Intervention Type DRUG

Single intravenous dose of 2 mg NRL972

Single intravenous dose of 2 mg NRL972

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Subjects meeting the following conditions will be eligible for enrolment:

General - all subjects

1. Males or females (females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
2. Caucasian
3. BMI: between 19 and 34 kg.m-2
4. BW: between 45 and 110 kg
5. willing and able to provide informed consent

Healthy volunteers (group N)
6. Age: 18 - 40 years (inclusive) and \> 60 years
7. Assessed as healthy based on the pre-study examination

Hepatic cirrhosis
8. Age: 18 - 75 years
9. 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

1. Previous participation in the trial
2. Participant in any other trial during the last 90 days
3. Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
4. History of any clinically relevant allergy
5. Presence of acute or chronic infection
6. Uncontrolled diabetes mellitus
7. Resting systolic blood pressure \> 160 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
8. Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
9. Positive HIV test
10. Positive alcohol or urine drug test on recruitment
11. Daily use of \> 30 gr alcohol
12. Smoking more than 15 cigarettes/day or equivalent of other tobacco products
13. Use of prohibited medication
14. Suspicion or evidence that the subject is not trustworthy and reliable
15. 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
16. Positive pregnancy test
17. Lactating
18. Not using appropriate contraception in premenopausal women

All healthy subjects
19. Presence or history of any relevant comorbidity
20. Presence of any relevant abnormality in the laboratory safety tests, especially low Hemoglobin, increased liver enzymes, reduced serum creatinine
21. Positive serology for HBsAg, anti HBc and anti HCV
22. History of alcohol and/or drug abuse

Patients with hepatic disease
23. Biliary liver cirrhosis
24. Liver impairment due to space-occupying processes (e.g. carcinoma)
25. State after liver transplantation or patient scheduled for liver transplantation

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes