NCT01526213

Brief Summary

Purpose: Grapefruit juice is one of the most extensively studied dietary/natural substances shown to interact with a variety of medications. However, unanswered questions remain regarding the causative ingredients and mechanisms underlying such drug-grapefruit juice interactions. Compounds in grapefruit juice called furanocoumarins have been established as major causative ingredients, which act by inhibiting the elimination (metabolism) of drugs, leading to increased circulating drug concentrations. Increased drug concentrations can in turn lead to increased drug potency or even toxicity. Grapefruit juice also has been shown, paradoxically, to decrease circulating concentrations of some drugs, including the non-sedating antihistamine agent, fexofenadine (Allegra), which undergoes negligible metabolism. Whether or not furanocoumarins mediate the decrease in fexofenadine concentrations is unknown. The purpose of the proposed study is to compare the effects of a "furanocoumarin-free" grapefruit juice with grapefruit juice on circulating concentrations of fexofenadine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

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

September 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 4, 2013

Completed
Last Updated

May 30, 2017

Status Verified

December 1, 2012

Enrollment Period

7 months

First QC Date

January 31, 2012

Results QC Date

March 3, 2012

Last Update Submit

April 21, 2017

Conditions

Food-drug Interaction

Outcome Measures

Primary Outcomes (1)

  • Primary Pharmacokinetic Measure: Area Under the Curve (AUC)

    0-72 hours

Study Arms (6)

Sequence 1: Water, GFJ, FC-free GFJ

OTHER

This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), or furanocoumarin (FC)-free grapefruit juice.

Drug: Fexofenadine

Sequence 2: Water, FC-free GFJ, GFJ

OTHER

This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), or furanocoumarin (FC)-free grapefruit juice.

Drug: Fexofenadine

Sequence 3: GFJ, FC-free GFJ, Water

OTHER

This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), or furanocoumarin (FC)-free grapefruit juice.

Drug: Fexofenadine

Sequence 4: GFJ, Water, FC-free GFJ

OTHER

This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), or furanocoumarin (FC)-free grapefruit juice.

Drug: Fexofenadine

Sequence 5: FC-free GFJ, GFJ, Water

OTHER

This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), or furanocoumarin (FC)-free grapefruit juice.

Drug: Fexofenadine

Sequence 6: FC-free GFJ, Water, GFJ

OTHER

This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), or furanocoumarin (FC)-free grapefruit juice.

Drug: Fexofenadine

Interventions

FexofenadineDRUG

This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice, or furanocoumarin-free grapefruit juice.

Also known as: Screening: labs, physical exam, Placement of an intravenous (IV) line, Collection of blood over 72 hours
Sequence 1: Water, GFJ, FC-free GFJSequence 2: Water, FC-free GFJ, GFJSequence 3: GFJ, FC-free GFJ, WaterSequence 4: GFJ, Water, FC-free GFJSequence 5: FC-free GFJ, GFJ, WaterSequence 6: FC-free GFJ, Water, GFJ

Eligibility Criteria

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

You may qualify if:

  • Men or women between the ages of 18 and 65
  • Normal screening laboratory test results
  • Able to understand the informed consent form
  • Willing to abstain from grapefruit products and all fruit juices for one week prior to and during the study
  • Willing to abstain from alcohol and caffeinated beverages the evening prior to each study day

You may not qualify if:

  • History of intolerance to grapefruit products
  • History of any allergy or hypersensitivity to grapefruit products or fexofenadine
  • History of significant medical conditions that the study physician believes would increase risk
  • History of significant alcohol abuse and/or illicit drug use
  • Tobacco use within the month preceding the study
  • Pregnancy or breast-feeding
  • Taking concomitant medications, both prescription and non-prescription (including herbal products), known to alter fexofenadine blood levels or P-gp and/or OATP activity (women stabilized on hormonal methods of birth control will be allowed to participate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Clinical and Translational Research Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

fexofenadineRestraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Results Point of Contact

Title
Mary F. Paine, RPh, PhD
Organization
UNC-Chapel Hill
mpaine@unc.edu
919-966-9984

Study Officials

  • Mary F Paine, PhD

    UNC-Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 3, 2012

Study Start

September 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2011

Last Updated

May 30, 2017

Results First Posted

February 4, 2013

Record last verified: 2012-12

Locations

US(1)