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

Phase 1

Completed

• Conditions: Cytochrome; Pharmacokinetics
• Interventions: Drug: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam

• Registration Number: NCT01187862
• Lead Sponsor: University Hospital, Basel, Switzerland

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 available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Primary Completion: 2011-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Basel cocktail	caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam	-

Primary Outcome Measures

Name	Time	Method
Assessment of phenotyping measures of seven drugs used as a cocktail

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Basel, Switzerland