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Mechanisms Underlying Drug-Diet Interactions

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01034124
First received: December 15, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

Similar to the well publicized "grapefruit juice effect", ongoing studies are evaluating the interaction potential of other dietary substances on drug disposition. This study is designed to determine whether the mechanism underlying the enhancement of the anticoagulative effect of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type interaction with midazolam.


Condition Intervention
Pharmacokinetics
 Drug: warfarin, vitamin K, midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Mechanisms Underlying Drug-Diet Interactions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • AUC [ Time Frame: 0-96 hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax [ Time Frame: varies ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Water Drug: warfarin, vitamin K, midazolam
warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
Other Names:
  • Coumadin
  • Mephyton
  • Versed
Active Comparator: Cranberry juice Drug: warfarin, vitamin K, midazolam
warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
Other Names:
  • Coumadin
  • Mephyton
  • Versed

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-65 years of age
  • Healthy
  • Not taking medications known to modulate CYP2C9 and CYP3A activity
  • Able to understand the consent process

Exclusion Criteria:

  • Allergy to cranberry products, warfarin, vitamin K, or midazolam
  • Pregnant or breast-feeding women
  • Baseline INR >1.2
  • History of significant medical conditions that could increase risk
  • Concomitant medications known to modulate CYP2C9 and CYP3A activity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034124

Locations
United States, North Carolina
UNC-Chapel Hill General Clinical Research Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Mary F Paine, Ph.D. UNC-Chapel Hill
  More Information

Publications:

Responsible Party: Mary F. Paine, The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01034124     History of Changes
Other Study ID Numbers: UNC-CH 05-2951
Study First Received: December 15, 2009
Last Updated: December 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
warfarin
midazolam
cranberry juice
pharmacokinetics

Additional relevant MeSH terms:
Midazolam
Vitamin K
Vitamins
Warfarin
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants
Hematologic Agents
Anticoagulants

ClinicalTrials.gov processed this record on May 16, 2013