Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary F. Paine, PhD, RPh, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01526213
First received: January 31, 2012
Last updated: December 29, 2012
Last verified: December 2012
Results First Received: March 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Food-drug Interaction
Intervention: Drug: Fexofenadine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Screening began in September 2009. Potential eligible subjects presented for a screening visit at the UNC Clinical and Translational Research Center (CTRC) within 1 month prior to the first day of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No significant events/approaches for overall study following participant enrollment but prior to group assignment. 18 subjects recruited and screened. No exclusions.

Reporting Groups
  Description
Sequence 1: Water, GFJ, Furanocoumarin-free GFJ By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
Sequence 2: Water, Furanocoumarin-free GFJ, GFJ By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
Sequence 3: GFJ, Furanocoumarin-free GFJ, Water By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
Sequence 4: GFJ, Water, Furanocoumarin-free GFJ By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
Sequence 5: Furanocoumarin-free GFJ, GFJ, Water By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
Sequence 6: Furanocoumarin-free GFJ, Water, GFJ By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.

Participant Flow for 5 periods

Period 1:   Period 1 (5 Days)
    Sequence 1: Water, GFJ, Furanocoumarin-free GFJ     Sequence 2: Water, Furanocoumarin-free GFJ, GFJ     Sequence 3: GFJ, Furanocoumarin-free GFJ, Water     Sequence 4: GFJ, Water, Furanocoumarin-free GFJ     Sequence 5: Furanocoumarin-free GFJ, GFJ, Water     Sequence 6: Furanocoumarin-free GFJ, Water, GFJ  
STARTED     3 [1]   3 [1]   3 [1]   3 [1]   3 [1]   3 [2]
COMPLETED     3 [3]   3 [3]   3 [3]   3 [3]   3 [3]   3 [3]
NOT COMPLETED     0     0     0     0     0     0  
[1] 3-way crossover study. Each subject was assigned to one of six sequences.
[2] 3-way crossover study. Each subject was assigned to (and completed) one of six sequences.
[3] Each subject served as his/her own control and completed assigned sequence.

Period 2:   Washout 1 (10 Days)
    Sequence 1: Water, GFJ, Furanocoumarin-free GFJ     Sequence 2: Water, Furanocoumarin-free GFJ, GFJ     Sequence 3: GFJ, Furanocoumarin-free GFJ, Water     Sequence 4: GFJ, Water, Furanocoumarin-free GFJ     Sequence 5: Furanocoumarin-free GFJ, GFJ, Water     Sequence 6: Furanocoumarin-free GFJ, Water, GFJ  
STARTED     3     3     3     3     3     3  
COMPLETED     3     3     3     3     3     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Period 2 (5 Days)
    Sequence 1: Water, GFJ, Furanocoumarin-free GFJ     Sequence 2: Water, Furanocoumarin-free GFJ, GFJ     Sequence 3: GFJ, Furanocoumarin-free GFJ, Water     Sequence 4: GFJ, Water, Furanocoumarin-free GFJ     Sequence 5: Furanocoumarin-free GFJ, GFJ, Water     Sequence 6: Furanocoumarin-free GFJ, Water, GFJ  
STARTED     3 [1]   3 [1]   3 [1]   3 [1]   3 [1]   3 [1]
COMPLETED     3 [2]   3 [2]   3 [3]   3 [3]   3 [3]   3 [3]
NOT COMPLETED     0     0     0     0     0     0  
[1] 3-way crossover study. Each subject was assigned to one of six sequences.
[2] Each subject served as his/her own control and completed assigned sequence.
[3] 3-way crossover study. Each subject was his/her own control and underwent all 3 treatments.

Period 4:   Washout 2 (10 Days)
    Sequence 1: Water, GFJ, Furanocoumarin-free GFJ     Sequence 2: Water, Furanocoumarin-free GFJ, GFJ     Sequence 3: GFJ, Furanocoumarin-free GFJ, Water     Sequence 4: GFJ, Water, Furanocoumarin-free GFJ     Sequence 5: Furanocoumarin-free GFJ, GFJ, Water     Sequence 6: Furanocoumarin-free GFJ, Water, GFJ  
STARTED     3     3     3     3     3     3  
COMPLETED     3     3     3     3     3     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 5:   Period 3 (5 Days)
    Sequence 1: Water, GFJ, Furanocoumarin-free GFJ     Sequence 2: Water, Furanocoumarin-free GFJ, GFJ     Sequence 3: GFJ, Furanocoumarin-free GFJ, Water     Sequence 4: GFJ, Water, Furanocoumarin-free GFJ     Sequence 5: Furanocoumarin-free GFJ, GFJ, Water     Sequence 6: Furanocoumarin-free GFJ, Water, GFJ  
STARTED     3 [1]   3 [1]   3 [1]   3 [1]   3 [1]   3 [1]
COMPLETED     3 [2]   3 [2]   3 [2]   3 [2]   3 [2]   3 [2]
NOT COMPLETED     0     0     0     0     0     0  
[1] 3-way crossover study. Each subject was assigned to one of six sequences.
[2] Each subject served as his/her own control and completed assigned sequence.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sequence 1: Water, GFJ, Furanocoumarin-free GFJ 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), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
Sequence 2: Water, Furanocoumarin-free GFJ, GFJ 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), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
Sequence 3: GFJ, Furanocoumarin-free GFJ, Water 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), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
Sequence 4: GFJ, Water, Furanocoumarin-free GFJ 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), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
Sequence 5: Furanocoumarin-free GFJ, GFJ, Water 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), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
Sequence 6: Furanocoumarin-free GFJ, Water, GFJ 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), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
Total Total of all reporting groups

Baseline Measures
    Sequence 1: Water, GFJ, Furanocoumarin-free GFJ     Sequence 2: Water, Furanocoumarin-free GFJ, GFJ     Sequence 3: GFJ, Furanocoumarin-free GFJ, Water     Sequence 4: GFJ, Water, Furanocoumarin-free GFJ     Sequence 5: Furanocoumarin-free GFJ, GFJ, Water     Sequence 6: Furanocoumarin-free GFJ, Water, GFJ     Total  
Number of Participants  
[units: participants]
  3     3     3     3     3     3     18  
Age  
[units: years]
Mean ± Standard Deviation
             
Mean     26  ± 1.0     34  ± 17     51  ± 11     39  ± 11     33  ± 9.1     30  ± 7.5     36  ± 12  
Gender  
[units: participants]
             
Female     2     1     0     2     1     3     9  
Male     1     2     3     1     2     0     9  
Region of Enrollment  
[units: participants]
             
United States     3     3     3     3     3     3     18  



  Outcome Measures

1.  Primary:   Primary Pharmacokinetic Measure: Area Under the Curve (AUC)   [ Time Frame: 0-72 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mary F. Paine, RPh, PhD
Organization: UNC-Chapel Hill
phone: 919-966-9984
e-mail: mpaine@unc.edu


No publications provided


Responsible Party: Mary F. Paine, PhD, RPh, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01526213     History of Changes
Other Study ID Numbers: IRB 09-0788
Study First Received: January 31, 2012
Results First Received: March 3, 2012
Last Updated: December 29, 2012
Health Authority: United States: Institutional Review Board