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: April 16, 2015
Last verified: April 2015
  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   (Adult)
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

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: April 16, 2015
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Losartan
Metoprolol
Caffeine
Efavirenz
Omeprazole
Midazolam
Chlorzoxazone
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers

ClinicalTrials.gov processed this record on August 22, 2016