Trial Outcomes & Findings for Pharmacokinetic and Exploratory Electrocardiogram (ECG) Study (NCT NCT01018420)
NCT ID: NCT01018420
Last Updated: 2009-12-01
Results Overview
The maximum or peak concentration that colchicine reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose
Results posted on
2009-12-01
Participant Flow
Eighteen (18) healthy, non-smoking, adult male and female volunteers, consisting of university students and members of the community at large, were to be enrolled.
50 subjects screened, 28 were screen failures, 4 were alternates
Participant milestones
| Measure |
Colchicine
1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses \[4.8mg over 6 hours\]
|
Moxifloxacin
400 mg capsule at the 6 hour point
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
3
|
|
Overall Study
COMPLETED
|
15
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic and Exploratory Electrocardiogram (ECG) Study
Baseline characteristics by cohort
| Measure |
Colchicine
n=15 Participants
1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses \[4.8mg over 6 hours\]
|
Moxifloxacin
n=3 Participants
400 mg capsule at the 6 hour point
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18.0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age Continuous
|
30.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
21.3 years
STANDARD_DEVIATION 0.6 • n=7 Participants
|
28.7 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
3 participants
n=7 Participants
|
18.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-doseThe maximum or peak concentration that colchicine reaches in the plasma.
Outcome measures
| Measure |
Colchicine
n=15 Participants
1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses \[4.8mg over 6 hours\]
|
Hour 1
measured 1 hour after initial colchicine dose
|
Hour 3
measured 3 hours after initial colchicine dose
|
Hour 6
measured 6 hours after initial colchicine dose
|
Hour 7
measured 7 hours after initial colchicine dose
|
Hour 8
measured 8 hours after initial colchicine dose
|
Hour 10
measured 10 hours after initial colchicine dose
|
Hour 12
measured 12 hours after initial colchicine dose
|
Hour 23
measured 23 hours after initial colchicine dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
6.84 ng/mL
Standard Deviation 1.30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-doseThe area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Colchicine
n=15 Participants
1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses \[4.8mg over 6 hours\]
|
Hour 1
measured 1 hour after initial colchicine dose
|
Hour 3
measured 3 hours after initial colchicine dose
|
Hour 6
measured 6 hours after initial colchicine dose
|
Hour 7
measured 7 hours after initial colchicine dose
|
Hour 8
measured 8 hours after initial colchicine dose
|
Hour 10
measured 10 hours after initial colchicine dose
|
Hour 12
measured 12 hours after initial colchicine dose
|
Hour 23
measured 23 hours after initial colchicine dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
104.95 ng-hr/mL
Standard Deviation 24.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-doseThe 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 plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Colchicine
n=15 Participants
1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses \[4.8mg over 6 hours\]
|
Hour 1
measured 1 hour after initial colchicine dose
|
Hour 3
measured 3 hours after initial colchicine dose
|
Hour 6
measured 6 hours after initial colchicine dose
|
Hour 7
measured 7 hours after initial colchicine dose
|
Hour 8
measured 8 hours after initial colchicine dose
|
Hour 10
measured 10 hours after initial colchicine dose
|
Hour 12
measured 12 hours after initial colchicine dose
|
Hour 23
measured 23 hours after initial colchicine dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
118.20 ng-hr/mL
Standard Deviation 26.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours - measured 0.5 hr prior to first dose (baseline), then 1, 3, 6, 7, 8, 10, 12, and 23 hours after first doseThe QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. It is dependent on heart rate and is corrected (c) to aid interpretation via Fridericia's adjustment (F), and is reported as QTcF.
Outcome measures
| Measure |
Colchicine
n=15 Participants
1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses \[4.8mg over 6 hours\]
|
Hour 1
n=15 Participants
measured 1 hour after initial colchicine dose
|
Hour 3
n=15 Participants
measured 3 hours after initial colchicine dose
|
Hour 6
n=15 Participants
measured 6 hours after initial colchicine dose
|
Hour 7
n=15 Participants
measured 7 hours after initial colchicine dose
|
Hour 8
n=15 Participants
measured 8 hours after initial colchicine dose
|
Hour 10
n=15 Participants
measured 10 hours after initial colchicine dose
|
Hour 12
n=15 Participants
measured 12 hours after initial colchicine dose
|
Hour 23
n=15 Participants
measured 23 hours after initial colchicine dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Electrocardiogram (ECG) Evaluation of the QTcF Interval (Colchicine)
|
401.62 milliseconds
Standard Deviation 20.18
|
397.80 milliseconds
Standard Deviation 19.63
|
401.76 milliseconds
Standard Deviation 20.04
|
394.73 milliseconds
Standard Deviation 10.72
|
388.84 milliseconds
Standard Deviation 15.57
|
393.93 milliseconds
Standard Deviation 16.30
|
396.02 milliseconds
Standard Deviation 16.15
|
396.89 milliseconds
Standard Deviation 11.85
|
399.36 milliseconds
Standard Deviation 17.38
|
SECONDARY outcome
Timeframe: 24 hours - measured 0.5 hr prior to dose (baseline), then 1, 3, 6, 7, 8, 10, 12, and 23 hours after doseThe QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. It is dependent on heart rate and is corrected (c) to aid interpretation via Fridericia's adjustment (F), and is reported as QTcF.
Outcome measures
| Measure |
Colchicine
n=3 Participants
1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses \[4.8mg over 6 hours\]
|
Hour 1
n=3 Participants
measured 1 hour after initial colchicine dose
|
Hour 3
n=3 Participants
measured 3 hours after initial colchicine dose
|
Hour 6
n=3 Participants
measured 6 hours after initial colchicine dose
|
Hour 7
n=3 Participants
measured 7 hours after initial colchicine dose
|
Hour 8
n=3 Participants
measured 8 hours after initial colchicine dose
|
Hour 10
n=3 Participants
measured 10 hours after initial colchicine dose
|
Hour 12
n=3 Participants
measured 12 hours after initial colchicine dose
|
Hour 23
n=3 Participants
measured 23 hours after initial colchicine dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Electrocardiogram (ECG) Evaluation of the QTcF Interval (Moxifloxacin)
|
402.11 milliseconds
Standard Deviation 12.04
|
398.89 milliseconds
Standard Deviation 1.65
|
403.67 milliseconds
Standard Deviation 17.91
|
397.00 milliseconds
Standard Deviation 8.46
|
397.89 milliseconds
Standard Deviation 8.31
|
397.44 milliseconds
Standard Deviation 2.59
|
402.67 milliseconds
Standard Deviation 13.23
|
405.22 milliseconds
Standard Deviation 17.64
|
416.00 milliseconds
Standard Deviation 13.68
|
Adverse Events
Colchicine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Moxifloxacin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Colchicine
n=15 participants at risk
1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses \[4.8mg over 6 hours\]
|
Moxifloxacin
n=3 participants at risk
400 mg capsule at the 6 hour point
|
|---|---|---|
|
Gastrointestinal disorders
diarrhoea
|
100.0%
15/15 • Number of events 15
|
0.00%
0/3
|
|
Gastrointestinal disorders
flatulence
|
6.7%
1/15 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
nausea
|
46.7%
7/15 • Number of events 7
|
0.00%
0/3
|
|
General disorders
vessel puncture site pain
|
6.7%
1/15 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
dizziness
|
6.7%
1/15 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
headache
|
6.7%
1/15 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
6.7%
1/15 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
nasopharyngitis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
6.7%
1/15 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
vomiting
|
40.0%
6/15 • Number of events 8
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60