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

NCT ID: NCT01187862

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31

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.

Conditions

Cytochrome; Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Basel cocktail

Group Type: OTHER

caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam

Intervention Type: DRUG

Interventions

caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Haschke, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2010 DR 1136

Identifier Type: OTHER

Identifier Source: secondary_id

EKBB-94/10

Identifier Type: -

Identifier Source: org_study_id