Trial Outcomes & Findings for Drug-Food Interaction Study of Seville Orange Juice and Colchicine (NCT NCT00960193)
NCT ID: NCT00960193
Last Updated: 2011-06-08
Results Overview
The maximum or peak concentration that colchicine reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.
Results posted on
2011-06-08
Participant Flow
Participant milestones
| Measure |
Colchicine Alone, Colchicine With Seville Orange Juice
On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
|
|---|---|
|
Colchicine Alone
STARTED
|
24
|
|
Colchicine Alone
COMPLETED
|
24
|
|
Colchicine Alone
NOT COMPLETED
|
0
|
|
14 Day Washout Period
STARTED
|
24
|
|
14 Day Washout Period
COMPLETED
|
23
|
|
14 Day Washout Period
NOT COMPLETED
|
1
|
|
Seville Orange Juice Alone
STARTED
|
23
|
|
Seville Orange Juice Alone
COMPLETED
|
23
|
|
Seville Orange Juice Alone
NOT COMPLETED
|
0
|
|
Colchicine With Seville Orange Juice
STARTED
|
23
|
|
Colchicine With Seville Orange Juice
COMPLETED
|
23
|
|
Colchicine With Seville Orange Juice
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Colchicine Alone, Colchicine With Seville Orange Juice
On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
|
|---|---|
|
14 Day Washout Period
Withdrawal by Subject
|
1
|
Baseline Characteristics
Drug-Food Interaction Study of Seville Orange Juice and Colchicine
Baseline characteristics by cohort
| Measure |
Colchicine Alone, Colchicine With Seville Orange Juice
n=24 Participants
On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age Continuous
|
25.83 years
STANDARD_DEVIATION 7.73 • n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.Population: 24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose.
The maximum or peak concentration that colchicine reaches in the plasma.
Outcome measures
| Measure |
Colchicine Alone
n=23 Participants
Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
|
Colchicine With Seville Orange Juice
n=23 Participants
On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Colchicine
|
2,328.44 pg/mL
Standard Deviation 980.15
|
1,668.33 pg/mL
Standard Deviation 423.36
|
PRIMARY outcome
Timeframe: Serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.Population: 24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose.
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Colchicine Alone
n=23 Participants
Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
|
Colchicine With Seville Orange Juice
n=23 Participants
On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
10,261.93 pg*hr/mL
Standard Deviation 4,307.62
|
7,634.86 pg*hr/mL
Standard Deviation 2,678.60
|
PRIMARY outcome
Timeframe: Serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.Population: 24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose. The pharmacokinetic parameter, AUC(0-∞), could not be determined for 1 subject in the Colchicine Alone group and for 2 subjects in the Colchicine with Seville orange juice group.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Colchicine Alone
n=22 Participants
Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
|
Colchicine With Seville Orange Juice
n=21 Participants
On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
12,071.30 pg*hr/mL
Standard Deviation 4,657.94
|
9,148.05 pg*hr/mL
Standard Deviation 2,743.54
|
Adverse Events
Colchicine Alone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Seville Orange Juice Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colchicine With Seville Orange Juice
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Colchicine Alone
n=24 participants at risk
Each subject received one 0.6 mg colchicine tablet on Day 1 at after an overnight fast, followed by a washout period of 14 days.
|
Seville Orange Juice Alone
n=23 participants at risk
On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening.
|
Colchicine With Seville Orange Juice
n=23 participants at risk
On Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
|
|---|---|---|---|
|
General disorders
Pain
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/24
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
4.3%
1/23 • Number of events 1
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
4.3%
1/23 • Number of events 1
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
|
General disorders
Fever
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60