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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01187862
First received: August 23, 2010
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Cytochrome
Pharmacokinetics
Drug: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

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

Enrollment: 16
Study Start Date: July 2010
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Basel cocktail Drug: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187862

Locations
Switzerland
University Hospital
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Manuel Haschke, MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01187862     History of Changes
Other Study ID Numbers: EKBB-94/10, 2010 DR 1136
Study First Received: August 23, 2010
Last Updated: February 8, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Metoprolol
Losartan
Metoprolol succinate
Midazolam
Caffeine
Chlorzoxazone
Efavirenz
Omeprazole
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Adjuvants, Anesthesia
Central Nervous System Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on September 30, 2014