Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers
- Registration Number
- NCT00856713
- Lead Sponsor
- Norgine
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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
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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
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
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Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
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History of any clinically relevant allergy
-
Presence of acute or chronic infection
-
Uncontrolled diabetes mellitus
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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
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Smoking more than 15 cigarettes/day or equivalent of other tobacco products
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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
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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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 EF NRL972 Healthy elderly females 5 CTP-A NRL972 Patients with hepatic cirrhosis CTP-class A 6 CTP-BC NRL972 Patients with hepatic cirrhosis CTP-class B and C 1 YM NRL972 Healthy young males 2 EM NRL972 Healthy elderly males 3 YF NRL972 Healthy young females
- Primary Outcome Measures
Name Time Method Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis Up to 4 hrs post administration of NRL972
- Secondary Outcome Measures
Name Time Method Adverse events and changes in physical findings from baseline Up to 4 hours post-dosing Effects on vital signs: blood pressure, pulse rate Up to 4 hours post-dosing Effects on electrocardiogram Up to 4 hours post-dosing Changes in haematology, clinical chemistry, urinalysis Up to 4 hours post-dosing
Trial Locations
- Locations (1)
UMHAPT St Ivan Rilski's University Hospital
š§š¬Sofia, Bulgaria