Trial Outcomes & Findings for Drug-Drug Interaction Study Between Colchicine and Atorvastatin (NCT NCT00960323)
NCT ID: NCT00960323
Last Updated: 2010-03-30
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 prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.
Results posted on
2010-03-30
Participant Flow
Forty-two volunteers were screened for participation in this study. Eight were screen failures, four were not needed, four withdrew consent and two had a schedule conflict.
Participant milestones
| Measure |
Colchicine, Atorvastatin, Colchicine and Atorvastatin
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 the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
|
|---|---|
|
Colchicine Alone
STARTED
|
24
|
|
Colchicine Alone
COMPLETED
|
24
|
|
Colchicine Alone
NOT COMPLETED
|
0
|
|
14 Day Washout Period
STARTED
|
24
|
|
14 Day Washout Period
COMPLETED
|
24
|
|
14 Day Washout Period
NOT COMPLETED
|
0
|
|
Atorvastatin Alone
STARTED
|
24
|
|
Atorvastatin Alone
COMPLETED
|
23
|
|
Atorvastatin Alone
NOT COMPLETED
|
1
|
|
Colchicine and Atorvastatin
STARTED
|
23
|
|
Colchicine and Atorvastatin
COMPLETED
|
23
|
|
Colchicine and Atorvastatin
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Colchicine, Atorvastatin, Colchicine and Atorvastatin
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 the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
|
|---|---|
|
Atorvastatin Alone
Withdrawal by Subject
|
1
|
Baseline Characteristics
Drug-Drug Interaction Study Between Colchicine and Atorvastatin
Baseline characteristics by cohort
| Measure |
Colchicine, Atorvastatin, Colchicine and Atorvastatin
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 the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
26.29 years
STANDARD_DEVIATION 6.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 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
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 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
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.Population: 24 subjects were enrolled in this study. One subject withdrew from the study prior to Period II check in due to a schedule conflict.
The maximum or peak concentration that colchicine reaches in the plasma.
Outcome measures
| Measure |
Colchicine Alone
n=23 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.
|
Colchicine With Atorvastatin
n=23 Participants
On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Colchicine
|
2,023.29 pg/mL
Standard Deviation 903.14
|
2,487.96 pg/mL
Standard Deviation 646.99
|
PRIMARY outcome
Timeframe: Serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.Population: 24 subjects were enrolled in this study. One subject withdrew from the study prior to Period II check in due to a schedule conflict.
The 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 for colchicine.
Outcome measures
| Measure |
Colchicine Alone
n=23 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.
|
Colchicine With Atorvastatin
n=23 Participants
On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
8,717.33 pg*hr/mL
Standard Deviation 4,208.19
|
10,714.92 pg*hr/mL
Standard Deviation 4,060.71
|
PRIMARY outcome
Timeframe: Serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.Population: 24 subjects were enrolled in this study. One subject withdrew prior to Period II check-in. The pharmacokinetic parameter, AUC(0-∞), could not be determined for 1 subject in the Colchicine Alone group and for 4 subjects in the Colchicine with Atorvastatin 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 plasma concentration to the elimination rate constant for colchicine.
Outcome measures
| Measure |
Colchicine Alone
n=22 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.
|
Colchicine With Atorvastatin
n=19 Participants
On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
9,592.53 pg*hr/mL
Standard Deviation 3,349.19
|
11,043.58 pg*hr/mL
Standard Deviation 3,867.03
|
Adverse Events
Colchicine Alone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Atorvastatin Alone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Colchicine and Atorvastatin
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
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.
|
Atorvastatin Alone
n=24 participants at risk
On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast.
|
Colchicine and Atorvastatin
n=23 participants at risk
On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
|
|---|---|---|---|
|
Eye disorders
Ocular hyperaemia
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
|
General disorders
Fatigue
|
0.00%
0/24
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 2
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
4.3%
1/23 • Number of events 1
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
8.3%
2/24 • Number of events 2
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/24
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
8.3%
2/24 • Number of events 2
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/24
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
0.00%
0/23
24 subjects were enrolled in this study. One subject withdrew consent prior to Period II check-in.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60