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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187862
• Other study ID #: EKBB-94/10
• Secondary ID: 2010 DR 1136
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2010
• Last updated: April 16, 2015
• Start date: July 2010

Study information

• Verified date: April 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cytochrome
• Pharmacokinetics

Intervention

Drug:
• caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of phenotyping measures of seven drugs used as a cocktail