Safety, tolerability and pharmacokinetics of Ginkgo biloba special extract EGb 761® in patients with hepatic dysfunction
| ISRCTN | ISRCTN94562148 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94562148 |
| Secondary identifying numbers | 523001.01.092 |
- Submission date
- 02/10/2009
- Registration date
- 30/11/2009
- Last edited
- 30/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Z. Krastev
Scientific
Scientific
Deptartment of Gastroenterology
UMHAPT Sveti Ivan Rilski's University Hospital
15, I. Geshov Str.
Sofia
1431
Bulgaria
Study information
| Study design | Single-centre controlled open-label parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Single-centre, open-label, parallel-group trial to study the in-vivo effects of impaired hepatic function on the safety, tolerability and pharmacokinetics of Ginkgo biloba special extract EGb 761® in man |
| Study acronym | EGb 761®: Impaired Hepatic Function |
| Study objectives | To describe the pharmacokinetics, safety, and tolerability of single oral doses of EGb 761® in hepatic dysfunction relative to matched healthy controls. |
| Ethics approval(s) | Ethics Committee MHAT "St. Ivan Rilski" approved on the 25th August 2009 (ref: 16/25.08.2009) |
| Health condition(s) or problem(s) studied | Liver cirrhosis |
| Intervention | 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 visit for eligibility assessment within 21 to 2 days before hospitalisation. For each period, the subjects are hospitalised in the study clinic from the evening before dosing until 24.00 hours after dosing. Periods are at least one week apart for wash-out. An end-of-trial safety follow-up visit is scheduled within one week after Period 2. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | EGb 761® |
| Primary outcome measure | 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 outcome measures | No secondary outcome measures |
| Overall study start date | 01/11/2009 |
| Completion date | 28/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 28/02/2010 |
Locations
Countries of recruitment
- Bulgaria
Study participating centre
Deptartment of Gastroenterology
Sofia
1431
Bulgaria
1431
Bulgaria
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
| Website | http://www.schwabepharma.com/international/ |
|---|---|
"ROR" |
https://ror.org/043rrkc78 |
Funders
Funder type
Industry
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
