Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers

Hepatic Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856713
• Other study ID #: NRL972-01/2005 (ACPS)
• 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. 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

• Hepatic Cirrhosis
• Liver Cirrhosis

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