Status:
COMPLETED
Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Cytochrome
Pharmacokinetics
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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, CYP2...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01187862
Start Date
July 1 2010
Last Update
April 17 2015
Active Locations (1)
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1
University Hospital
Basel, Switzerland, 4031