Mechanisms Underlying Drug-Diet Interactions

Pharmacokinetics Clinical Trial

Official title:

Mechanisms Underlying Drug-Diet Interactions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034124
• Other study ID #: UNC-CH 05-2951
• Status: Completed
• Phase: N/A
• First received: December 15, 2009
• Last updated: December 15, 2009
• Start date: January 2007
• Est. completion date: June 2008

Study information

• Verified date: December 2009
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• warfarin, vitamin K, midazolam
warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)

Locations

Country	Name	City	State
United States	UNC-Chapel Hill General Clinical Research Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & 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.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC		0-96 hr	No
Secondary	Cmax		varies	No