Status:
COMPLETED
Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers
Lead Sponsor:
Norgine
Conditions:
Hepatic Cirrhosis
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh \[CTP\...
Eligibility Criteria
Inclusion
- General - all subjects
- Males or females (females of non-childbearing potential or of childbearing 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) e.g. \> 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 Nonalcoholic steatohepatitis (NASH)
- Age: 18 - 75 years
- Diagnosis of NASH confirmed by liver biopsy
Exclusion
- 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 450 mL within the last 3 months
- History of any clinically relevant allergy
- Uncontrolled diabetes mellitus or any further intolerability of the Galactose test
- Presence of acute or chronic infection
- 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
- Clinically relevant ECG-abnormalities that constitute a contraindication for the Lido-cain-MEG'-X-test
- 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 (list of past and present diseases will be reviewed by an expert panel)
- Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes, reduced serum creatinine (laboratory test abnormalities will be reviewed by an expert panel)
- 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
- Fluctuating or rapidly deteriorating hepatic function
- Significant bleeding diathesis
- Oesophageal bleeding within the last 8 weeks before study entry
- Ascites \> 6 L on abdominal US
- Number Connection test: time to connect 25 consecutive numbers \> 30 sec
- Presence or history of any relevant comorbidity other than hepatic disease (list of past and present diseases will be reviewed by an expert panel)
- Clinically relevant abnormal laboratory values other than those associated or sufficiently explained by the existing liver disease (laboratory test abnormalities will be reviewed by an expert panel)
- History of drug or alcohol abuse within 2 months prior to dosing
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00856869
Start Date
August 1 2004
End Date
April 1 2005
Last Update
March 6 2009
Active Locations (1)
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1
UMHAPT St. Ivan Rilski's University Hospital
Sofia, Bulgaria, 1431