NCT01034124

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
Last Updated

December 17, 2009

Status Verified

December 1, 2009

Enrollment Period

10 months

First QC Date

December 15, 2009

Last Update Submit

December 15, 2009

Conditions

Pharmacokinetics

Keywords

warfarinmidazolamcranberry juicepharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • AUC

    0-96 hr

Secondary Outcomes (1)

  • Cmax

    varies

Study Arms (2)

Water

PLACEBO COMPARATOR
Drug: warfarin, vitamin K, midazolam

Cranberry juice

ACTIVE COMPARATOR
Drug: warfarin, vitamin K, midazolam

Interventions

warfarin, vitamin K, midazolamDRUG

warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)

Also known as: Coumadin, Mephyton, Versed
Cranberry juiceWater

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC-Chapel Hill General Clinical Research Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Ngo N, Yan Z, Graf TN, Carrizosa DR, Kashuba AD, Dees EC, Oberlies NH, Paine MF. Identification of a cranberry juice product that inhibits enteric CYP3A-mediated first-pass metabolism in humans. Drug Metab Dispos. 2009 Mar;37(3):514-22. doi: 10.1124/dmd.108.024968. Epub 2008 Dec 29.

    PMID: 19114462RESULT

MeSH Terms

Interventions

WarfarinVitamin KMidazolamVitamin K 2

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesPolycyclic CompoundsBenzodiazepinesBenzazepinesQuinones

Study Officials

  • Mary F Paine, Ph.D.

    UNC-Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2009

First Posted

December 17, 2009

Study Start

January 1, 2007

Primary Completion

November 1, 2007

Study Completion

June 1, 2008

Last Updated

December 17, 2009

Record last verified: 2009-12

Locations

US(1)