Status:
COMPLETED
Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers
Lead Sponsor:
Norgine
Conditions:
Hepatic Cirrhosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00856713
Start Date
March 1 2006
Last Update
March 6 2009
Active Locations (1)
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1
UMHAPT St Ivan Rilski's University Hospital
Sofia, Bulgaria, 1431