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

University Hospital Basel

Status and phase

Completed

Phase 1

Conditions

Cytochrome

Pharmacokinetics

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01187862

EKBB-94/10

2010 DR 1136 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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