Trial Outcomes & Findings for Pharmacokinetic Study With Colchicine in Healthy Volunteers (NCT NCT01017003)
NCT ID: NCT01017003
Last Updated: 2009-11-20
Results Overview
maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing
Results posted on
2009-11-20
Participant Flow
Participant milestones
| Measure |
Colchicine - Single Dose, Twice Daily Dose, Final Single Dose
All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
|
|---|---|
|
Single Dose Colchicine 0.6 mg, Day 1
STARTED
|
13
|
|
Single Dose Colchicine 0.6 mg, Day 1
COMPLETED
|
13
|
|
Single Dose Colchicine 0.6 mg, Day 1
NOT COMPLETED
|
0
|
|
14 Day Washout Period
STARTED
|
13
|
|
14 Day Washout Period
COMPLETED
|
13
|
|
14 Day Washout Period
NOT COMPLETED
|
0
|
|
Colchicine 0.6 mg Twice Daily x 10 Days
STARTED
|
13
|
|
Colchicine 0.6 mg Twice Daily x 10 Days
COMPLETED
|
13
|
|
Colchicine 0.6 mg Twice Daily x 10 Days
NOT COMPLETED
|
0
|
|
Colchicine 0.6 mg Final Dose
STARTED
|
13
|
|
Colchicine 0.6 mg Final Dose
COMPLETED
|
13
|
|
Colchicine 0.6 mg Final Dose
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Study With Colchicine in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Colchicine - Single Dose, Twice Daily Dose, Final Single Dose
n=13 Participants
All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age Continuous
|
25.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosingPopulation: per protocol
maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions
Outcome measures
| Measure |
Colchicine Pharmacokinetics (Day 1)
n=13 Participants
0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
|
Colchicine Pharmacokinetics at Steady State (Day 25)
n=13 Participants
0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
|
|---|---|---|
|
Maximum Serum Concentration (Cmax)
|
2450.15 pg/mL
Standard Deviation 702.11
|
3553.15 pg/mL
Standard Deviation 843.45
|
PRIMARY outcome
Timeframe: 0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosingPopulation: by protocol
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (t), calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Colchicine Pharmacokinetics (Day 1)
n=13 Participants
0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
|
Colchicine Pharmacokinetics at Steady State (Day 25)
n=13 Participants
0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.
|
10494.66 pg-h/ml
Standard Deviation 3544.08
|
43576.96 pg-h/ml
Standard Deviation 9333.26
|
PRIMARY outcome
Timeframe: 0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosingPopulation: by protocol
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 plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Colchicine Pharmacokinetics (Day 1)
n=13 Participants
0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
|
Colchicine Pharmacokinetics at Steady State (Day 25)
n=13 Participants
0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf)
|
12268.18 pg-h/ml
Standard Deviation 4422.08
|
54198.77 pg-h/ml
Standard Deviation 9214.54
|
Adverse Events
Colchicine Pharmacokinetics (Day 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colchicine Pharmacokinetics at Steady State (Day 25)
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 Pharmacokinetics (Day 1)
n=13 participants at risk
0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
|
Colchicine Pharmacokinetics at Steady State (Day 25)
n=13 participants at risk
0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60