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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Caffeine; Chlorzoxazone; Efavirenz; Losartan; Metoprolol; Midazolam; Omeprazole

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