Condition category
Not Applicable
Date applied
19/10/2009
Date assigned
08/12/2009
Last edited
08/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Uwe Fuhr

ORCID ID

Contact details

Weyertal 76
Cologne
50931
Germany

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 measures

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

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

http://www.schwabepharma.com/international/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes