Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cytochrome, Pharmacokinetics

Intervention / Treatment
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* Drug: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Basel cocktail<br> | Drug: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of phenotyping measures of seven drugs used as a cocktail |  |  |