Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
750201.01.08
Study information
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
Acronym
Study hypothesis
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
The local medical ethics committee (Ethikkommission der Ärztekammer Nordrhein) approved on the 18th September 2009 (ref: 2009263)
Study design
Single centre double-blind randomised placebo-controlled cross-over comparative interaction study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase I
Drug names
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 trial start date
14/10/2009
Overall trial end date
23/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
16
Participant 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
Recruitment start date
14/10/2009
Recruitment end date
23/12/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Weyertal 76
Cologne
50931
Germany
Sponsor information
Organisation
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Sponsor details
Willmar-Schwabe-Strasse 4
Karlsruhe
76227
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list