Metabolic drug interaction profile of Silexan in vivo
| ISRCTN | ISRCTN74386009 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74386009 |
| Secondary identifying numbers | 750201.01.08 |
- Submission date
- 19/10/2009
- Registration date
- 08/12/2009
- Last edited
- 08/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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 Uwe Fuhr
Scientific
Scientific
Weyertal 76
Cologne
50931
Germany
Study information
| Study design | Single centre double-blind randomised placebo-controlled cross-over comparative interaction study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Single centre, double-blind, randomised, placebo-controlled, two-fold cross-over, drug cocktail phenotyping study on the in vivo interaction potential of Silexan (WS® 1265) with respect to the activities of cytochrome P-450 enzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) in healthy volunteers |
| Study objectives | The objective of the study is to assess the interaction potential of Silexan (WS® 1265) 160 mg once daily administration (s.i.d.) with respect to the activities of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. |
| Ethics approval(s) | The local medical ethics committee (Ethikkommission der Ärztekammer Nordrhein) approved on the 18th September 2009 (ref: 2009263) |
| Health condition(s) or problem(s) studied | Activities of cytochrome P-450 enzymes |
| Intervention | Silexan (WS® 1265) 160 mg soft gelatine capsule or placebo for 11 days each. There is a screening visit within 14 days before the first intake of study drug; 11 days of treatment (cross-over period 1); a wash out period of 3 weeks; 11 days treatment (cross-over period 2); and a follow up visit within 4 - 10 days after last intake of study drug. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Silexan (WS® 1265) |
| Primary outcome measure | 1. CYP1A2 as quantified using AUC0-t of caffeine in plasma 2. CYP2C9 as quantified using AUC0-t of tolbutamide in plasma 3. CYP2C19 as quantified using AUC0-t of omeprazole in plasma 4. CYP2D6 as quantified using AUC0-t of dextromethorphan in plasma 5. CYP3A4 as quantified using AUC0-t of midazolam in plasma All measured on day 11 to day 12: 17 blood collections from 0 - 24 hours. |
| Secondary outcome measures | 1. Pharmacokinetic parameters of the phenotyping substances 2. Safety parameters All measured on day 11 to day 12: 17 blood collections from 0 - 24 hours. |
| Overall study start date | 14/10/2009 |
| Completion date | 23/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 16 |
| Key inclusion criteria | 1. Willing and capable to confirm written consent 2. Caucasian male or female 3. Aged between 18 - 55 years 4. A body mass index (BMI) 19 - 29 kg/m^2 5. Healthy 6. Non-pregnant and non-lactating, and have a negative urine pregnancy test result if subject is female 7. Use reliable contraception, i.e. two methods simultaneously if subject is female and of childbearing potential |
| Key exclusion criteria | 1. Subjects with any relevant clinical abnormality 2. Subjects with a tendency to loose stools and/or subjects with the history of a relevant surgical abdominal intervention 3. Subjects with any cardiac arrhythmia, subjects with acute infections within the last two weeks 4. Subjects with a history of any allergic disease with clinical signs 5. Subjects with suspicion of hypersensitivity to the investigational medication 6. Subjects with a history of severe skin reactions 7. Subjects receiving any medication within 2 weeks prior to study start or during the study 8. Subjects who have taken a drug with a long half-life (greater than 24 hours) within four weeks before the first trial day 9. Subjects who received chronic drug treatment (greater than 3 days) within eight weeks before the first trial day 10. Subjects who donated blood within the last 4 weeks before the start of the present study 11. Actual smokers defined as subjects who smoked any cigarette during the last three months 12. Subjects who are known or suspected to be (social) drug dependent 13. Subjects with a history of alcohol or recreational drug addiction 14. Subjects with positive drug screening tests 15. Subjects who are not willing or able to abstain from alcohol, methylxanthine-containing beverages and foods, and grapefruit flesh/juice from 1 week prior to the study until the safety follow-up examination 16. Anticipated problems of successfully placing an indwelling venous catheter at both forearms |
| Date of first enrolment | 14/10/2009 |
| Date of final enrolment | 23/12/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Weyertal 76
Cologne
50931
Germany
50931
Germany
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
Willmar-Schwabe-Strasse 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 |
