Trial Outcomes & Findings for Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction? (NCT NCT01526213)
NCT ID: NCT01526213
Last Updated: 2017-05-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
0-72 hours
Results posted on
2017-05-30
Participant Flow
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.
No significant events/approaches for overall study following participant enrollment but prior to group assignment. 18 subjects recruited and screened. No exclusions.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|---|---|
|
Period 1 (5 Days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 1 (5 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 1 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 1 (10 Days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout 1 (10 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout 1 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (5 Days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 2 (5 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 2 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 2 (10 Days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout 2 (10 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout 2 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (5 Days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 3 (5 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 3 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?
Baseline characteristics by cohort
| Measure |
Sequence 1: Water, GFJ, Furanocoumarin-free GFJ
n=3 Participants
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
n=3 Participants
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
n=3 Participants
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
n=3 Participants
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
n=3 Participants
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
n=3 Participants
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
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Mean
|
26 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
34 years
STANDARD_DEVIATION 17 • n=7 Participants
|
51 years
STANDARD_DEVIATION 11 • n=5 Participants
|
39 years
STANDARD_DEVIATION 11 • n=4 Participants
|
33 years
STANDARD_DEVIATION 9.1 • n=21 Participants
|
30 years
STANDARD_DEVIATION 7.5 • n=8 Participants
|
36 years
STANDARD_DEVIATION 12 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
18 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 0-72 hoursOutcome measures
| Measure |
Water
n=18 Participants
For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
|
Grapefruit Juice
n=18 Participants
For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
|
Furanocoumarin-free Grapefruit Juice
n=18 Participants
For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
|
|---|---|---|---|
|
Primary Pharmacokinetic Measure: Area Under the Curve (AUC)
Water
|
4.2 micromolar*hr
Interval 1.7 to 8.4
|
4.2 micromolar*hr
Interval 1.7 to 8.4
|
4.2 micromolar*hr
Interval 1.7 to 8.4
|
|
Primary Pharmacokinetic Measure: Area Under the Curve (AUC)
Grapefruit juice
|
3.2 micromolar*hr
Interval 1.9 to 6.3
|
3.2 micromolar*hr
Interval 1.9 to 6.3
|
3.2 micromolar*hr
Interval 1.9 to 6.3
|
|
Primary Pharmacokinetic Measure: Area Under the Curve (AUC)
Modified grapefruit juice
|
3.1 micromolar*hr
Interval 1.9 to 5.9
|
3.1 micromolar*hr
Interval 1.9 to 5.9
|
3.1 micromolar*hr
Interval 1.9 to 5.9
|
Adverse Events
Sequence 1: Water, GFJ, Furanocoumarin-free GFJ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sequence 2: Water, Furanocoumarin-free GFJ, GFJ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sequence 3: GFJ, Furanocoumarin-free GFJ, Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sequence 4: GFJ, Water, Furanocoumarin-free GFJ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sequence 5: Furanocoumarin-free GFJ, GFJ, Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sequence 6: Furanocoumarin-free GFJ, Water, GFJ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place