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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00856713
Other study ID # NRL972-01/2005 (ACPS)
Secondary ID
Status Completed
Phase Phase 1
First received March 4, 2009
Last updated March 5, 2009
Start date March 2006

Study information

Verified date March 2009
Source Norgine
Contact n/a
Is FDA regulated No
Health authority Bulgaria: Ministry of Health
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date
Est. primary completion date August 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
NRL972
Single intravenous dose of 2 mg NRL972
NRL972
Single intravenous dose of 2 mg NRL972
NRL972
Single intravenous dose of 2 mg NRL972
NRL972
Single intravenous dose of 2 mg NRL972
NRL972
Single intravenous dose of 2 mg NRL972
NRL972
Single intravenous dose of 2 mg NRL972

Locations

Country Name City State
Bulgaria UMHAPT St Ivan Rilski's University Hospital Sofia

Sponsors (1)

Lead Sponsor Collaborator
Norgine

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis Up to 4 hrs post administration of NRL972 No
Secondary Adverse events and changes in physical findings from baseline Up to 4 hours post-dosing Yes
Secondary Effects on vital signs: blood pressure, pulse rate Up to 4 hours post-dosing Yes
Secondary Effects on electrocardiogram Up to 4 hours post-dosing Yes
Secondary Changes in haematology, clinical chemistry, urinalysis Up to 4 hours post-dosing Yes
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