Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called "Basel cocktail") can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4. |
|---|---|
| Condition | Cytochrome Pharmacokinetics |
| Intervention | Drug: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam |
| Phase | Phase 1 |
| Sponsor | University Hospital, Basel, Switzerland |
| Responsible Party | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier | NCT01187862 |
| First Received | August 23, 2010 |
| Last Updated | February 8, 2012 |
| Last verified | February 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 23, 2010 |
|---|---|
| Last Updated Date | February 8, 2012 |
| Start Date | July 2010 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Assessment of phenotyping measures of seven drugs used as a cocktail |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes |
|---|---|
| Official Title | Single-center, Randomized, Five-way Crossover Study to Investigate Low-dose Combinations of Caffeine, Efavirenz, Losartan, Omeprazole, Metoprolol, Chlorzoxazone and Midazolam ("Basel Cocktail") for Simultaneous Phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 in Healthy Male Subjects |
| Brief Summary | The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called "Basel cocktail") can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic |
| Condition |
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| Intervention | Drug: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam |
| Study Arm (s) | Other: Basel cocktail |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 16 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | February 2011 |
| Eligibility Criteria | Inclusion Criteria: - Signed informed consent - Male aged between 18 and 45 years - No clinically significant findings on the physical examination - Body mass index (BMI) between 18 and 28 kg/m2 - Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and heart rate (HR) 45-90 bpm (inclusive) - 12-lead electrocardiogram (ECG) without clinically relevant abnormalities - Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent - Negative results from urine drug screen - Ability to communicate well with the investigator and to understand and comply with the requirements of the study Exclusion Criteria: - Known hypersensitivity to any excipients of the drug formulations - Treatment with another investigational drug within 30 days prior to screening - History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening - Excessive caffeine consumption, defined as mor than 800 mg per day - History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug - Smoking within the last 3 months prior to screening - Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening - Loss of 250 ml or more of blood within 3 months prior to screening - Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol - Legal incapacity or limited legal capacity at screening |
| Gender | Male |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Switzerland |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01187862 |
|---|---|
| Other Study ID Numbers | EKBB-94/10 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | University Hospital, Basel, Switzerland |
| Study Sponsor | University Hospital, Basel, Switzerland |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Manuel Haschke, MD University Hospital, Basel, Switzerland |
| Verification Date | February 2012 |
Locations[ + expand ][ + ]
| University Hospital | Basel, Switzerland, 4031 |
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