Trial Outcomes & Findings for A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice (NCT NCT00984009)
NCT ID: NCT00984009
Last Updated: 2011-11-21
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, 24, 36, 48, 72, and 96 hours after colchicine dose administration
Results posted on
2011-11-21
Participant Flow
Twenty-two (22) healthy, non-smoking, non-obese, adult, male and female volunteers, consisting of members of the community at large, were enrolled in the study.
46 subjects screened, 13 were screen failures, 6 had schedule conflicts or were no shows for check-in, 1 was not screened per request of study site, 2 were transferred to a different study
Participant milestones
| Measure |
Colchicine Alone / With Grapefruit Juice
\[All subjects received each of the study treatments.\] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
|
|---|---|
|
Colchicine Alone
STARTED
|
22
|
|
Colchicine Alone
COMPLETED
|
22
|
|
Colchicine Alone
NOT COMPLETED
|
0
|
|
14 Day Washout Period
STARTED
|
22
|
|
14 Day Washout Period
COMPLETED
|
22
|
|
14 Day Washout Period
NOT COMPLETED
|
0
|
|
Grapefruit Juice Alone
STARTED
|
22
|
|
Grapefruit Juice Alone
COMPLETED
|
21
|
|
Grapefruit Juice Alone
NOT COMPLETED
|
1
|
|
Colchicine With Grapefruit Juice
STARTED
|
21
|
|
Colchicine With Grapefruit Juice
COMPLETED
|
21
|
|
Colchicine With Grapefruit Juice
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Colchicine Alone / With Grapefruit Juice
\[All subjects received each of the study treatments.\] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
|
|---|---|
|
Grapefruit Juice Alone
missed serving of grapefruit juice
|
1
|
Baseline Characteristics
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
Baseline characteristics by cohort
| Measure |
Colchicine Alone / With Grapefruit Juice
n=22 Participants
\[All subjects received each of the study treatments.\] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
|
|---|---|
|
Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
22 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=5 Participants
|
|
Age Continuous
|
26.9 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 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, 24, 36, 48, 72, and 96 hours after colchicine dose administrationThe maximum or peak concentration that colchicine reaches in the plasma.
Outcome measures
| Measure |
Colchicine Alone
n=21 Participants
Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
|
Colchicine With Grapefruit Juice
n=21 Participants
On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
2,172.96 pg/mL
Standard Deviation 652.99
|
1,971.10 pg/mL
Standard Deviation 398.80
|
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, 24, 36, 48, 72, and 96 hours after colchicine dose administrationThe 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=21 Participants
Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
|
Colchicine With Grapefruit Juice
n=21 Participants
On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
9,329.53 pg-hr/mL
Standard Deviation 3,367.85
|
8,823.40 pg-hr/mL
Standard Deviation 3,003.15
|
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, 24, 36, 48, 72, and 96 hours after colchicine dose administrationThe 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=21 Participants
Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
|
Colchicine With Grapefruit Juice
n=21 Participants
On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
11,079.98 pg-hr/mL
Standard Deviation 3,949.27
|
10,854.22 pg-hr/mL
Standard Deviation 4,140.12
|
Adverse Events
Colchicine Alone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Grapefruit Juice Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colchicine With Grapefruit Juice
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Colchicine Alone
n=22 participants at risk
Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
|
Grapefruit Juice Alone
n=22 participants at risk
On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals.
|
Colchicine With Grapefruit Juice
n=21 participants at risk
On Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
|
|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/22
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
headache
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/21
|
|
Nervous system disorders
cough
|
0.00%
0/22
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
chest congestion
|
0.00%
0/22
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
0.00%
0/22
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60