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

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ClinicalTrials.gov Identifier: NCT01187862
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : April 17, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cytochrome Pharmacokinetics Drug: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : July 2010
Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
U.S. FDA Resources

Arm Intervention/treatment
Basel cocktail Drug: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam

Primary Outcome Measures :
  1. Assessment of phenotyping measures of seven drugs used as a cocktail

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187862

University Hospital
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Manuel Haschke, MD University Hospital, Basel, Switzerland

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01187862     History of Changes
Other Study ID Numbers: EKBB-94/10
2010 DR 1136 ( Other Identifier: Swissmedic )
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers