Trial Outcomes & Findings for Drug-Drug Interaction Study Between Colchicine and Cyclosporine (NCT NCT00983931)
NCT ID: NCT00983931
Last Updated: 2009-10-15
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 15, 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
2009-10-15
Participant Flow
Twenty-four (24) healthy, non-smoking, male and female volunteers, consisting of volunteers from the community at large, were enrolled in the study.
41 subjects were screened, 11 were screen failures, 4 had schedule conflicts, 1 was transferred to a different study, and 1 was not needed
Participant milestones
| Measure |
Colchicine Alone / With Cyclosporine
\[All subjects received each of the study treatments.\] 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. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
|
|---|---|
|
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
|
|
Colchicine With Cyclosporine
STARTED
|
23
|
|
Colchicine With Cyclosporine
COMPLETED
|
23
|
|
Colchicine With Cyclosporine
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Colchicine Alone / With Cyclosporine
\[All subjects received each of the study treatments.\] 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. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
|
|---|---|
|
14 Day Washout Period
Physician Decision
|
1
|
Baseline Characteristics
Drug-Drug Interaction Study Between Colchicine and Cyclosporine
Baseline characteristics by cohort
| Measure |
Colchicine Alone / With Cyclosporine
n=24 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. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age Continuous
|
29.0 years
STANDARD_DEVIATION 6.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, 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 With Cyclosporine
n=23 Participants
On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
|
Colchicine Alone
n=23 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.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
8,817.48 pg/mL
Standard Deviation 2,223.80
|
2,720.04 pg/mL
Standard Deviation 1,137.85
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, 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 With Cyclosporine
n=23 Participants
On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
|
Colchicine Alone
n=23 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.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
39,828.11 pg-hr/mL
Standard Deviation 10,312.85
|
12,545.04 pg-hr/mL
Standard Deviation 5,854.46
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, 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 With Cyclosporine
n=23 Participants
On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
|
Colchicine Alone
n=23 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.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
47,312.02 pg-hr/mL
Standard Deviation 12,137.79
|
14,996.79 pg-hr/mL
Standard Deviation 7,789.77
|
Adverse Events
Colchicine Alone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Colchicine With Cyclosporine
Serious events: 0 serious events
Other events: 4 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 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
|
Colchicine With Cyclosporine
n=23 participants at risk
On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain upper
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
bacteriuria
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
contusion
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
dizziness
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
headache
|
4.2%
1/24 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pharynolaryngeal pain
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
throat irritation
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60