Liver cirrhosis Digestive System Fibrosis and cirrhosis of liver
Conditions
Interventions
Period 1: a single oral dose 120 mg Ginkgo biloba special extract EGb 761®
Period 2: a single oral dose 240 mg Ginkgo biloba special extract EGb 761®
The first period is preceded by a screening visi
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Aged 21 to 60 years of age 4. Body mass index (BMI) between 18 - 30 kg/m^2 5. Body weight between 45 - 100 kg 6. Willing and able to provide informed consent Healthy control subjects (CON): 7. Healthy based on the pre-study examination Patients with moderate hepatic dysfunction (CTP-class B) (HEP): 8. Stable compensated liver cirrhosis (cryptogenic, post-hepatitis, alcohol-related) with histological or macroscopic (e.g. laparascopy, biopsy, ultrasound sonography or other adequate imaging techniques) confirmation 9. Child-Turcotte-Pugh (CTP) class B (sum of CTP-scores: 7 - 9) 10. Liver Vascular Index by Doppler ultrasonography T 12 cm/sec
Exclusion criteria
Exclusion criteria: 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 (including hypersensitivity to the trial medications) 5. Presence of acute or chronic infection (HEP: other than related to the primary diagnosis - chronic hepatitis or chronic pancreatitis are no reason for exclusion) 6. Uncontrolled diabetes mellitus 7. Resting systolic blood pressure greater than 160 or less than 90 mmHg, diastolic blood pressure greater than 95 or less than 50 mmHg 8. Clinically relevant electrocardiogram (ECG)-abnormalities, prolonged QTc with greater than 450 msec in males and greater than 460 msec in females in particular 9. Positive human immunodeficiency virus (HIV) test 10. Positive alcohol or urine drug test on recruitment 11. Daily alcohol use of greater than 30 g alcohol 12. Smoking more than 10 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 understand 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 co-morbidity 20. Presence of any clinically relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes, increased serum creatinine 21. Positive serology for hepatitis B surface antigen (HBsAg), hepatitis B core antigen (anti-HBc) and hepatitis C virus antigen (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 26. Fluctuating or rapidly deteriorating hepatic function 27. Significant bleeding diathesis 28. Oesophageal bleeding within the last 8 weeks before study entry 29. More than moderate ascites on abdominal ultrasound (US) 30. Presence or history of any relevant co-morbidity other than hepatic disease 31. Clinically relevant abnormal laboratory values other than those associated or sufficiently explained by the existing liver disease, the cut-off level of serum haemoglobin for exclusion: 100 g/l 32. History of drug or alcohol abuse within 2 months prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical pharmacology criteria: 1. Pharmacokinetics: single-dose pharmacokinetics of relevant marker terpenes (Ginkgolide A, Ginkgolide B and Bilobalide) in plasma (optional: in urine) 2. Wellbeing and adverse events 3. Recumbent resting blood pressure and pulse rate 4. Physical examination 5. Clinical laboratory safety tests | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Bulgaria
Outcome results
None listed