Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes
Information source: University Hospital, Basel, Switzerland
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytochrome; Pharmacokinetics
Intervention: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University Hospital, Basel, Switzerland Official(s) and/or principal investigator(s):
Manuel Haschke, MD, Principal Investigator, Affiliation: University Hospital Basel
Overall contact:
Manuel Haschke, Phone: +41 61 328 68 66, Email: mhaschke@uhbs.ch
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.
Clinical Details
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
Study design: N/A
Primary outcome: Assessment of phenotyping measures of seven drugs used as a cocktail
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
Manuel Haschke, Phone: +41 61 328 68 66, Email: mhaschke@uhbs.ch
University Hospital, Basel 4031, Switzerland; Recruiting
Manuel Haschke, MD, Principal Investigator
Additional Information
Last updated: August 23, 2010
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