Trial Outcomes & Findings for Drug-Drug Interaction Study of Colchicine and Azithromycin (NCT NCT00983294)
NCT ID: NCT00983294
Last Updated: 2009-10-28
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 plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration
Results posted on
2009-10-28
Participant Flow
Twenty-four (24) healthy, non-smoking, male and female volunteers, consisting of members of the community at large, were to be enrolled.
40 subjects screened, 6 were screen failures, 6 had schedule conflicts, 3 transferred to another study, 1 was not needed
Participant milestones
| Measure |
Colchicine Alone / With Azithromycin (at Steady State)
\[All subjects received each of the study treatments.\] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30 am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250mg azithromycin tablet at 7:30 am after 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
|
22
|
|
14 Day Washout Period
NOT COMPLETED
|
2
|
|
Azithromycin Alone
STARTED
|
22
|
|
Azithromycin Alone
COMPLETED
|
22
|
|
Azithromycin Alone
NOT COMPLETED
|
0
|
|
Colchicine With Azithromycin
STARTED
|
22
|
|
Colchicine With Azithromycin
COMPLETED
|
21
|
|
Colchicine With Azithromycin
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Colchicine Alone / With Azithromycin (at Steady State)
\[All subjects received each of the study treatments.\] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30 am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250mg azithromycin tablet at 7:30 am after an overnight fast.
|
|---|---|
|
14 Day Washout Period
Withdrawal by Subject
|
2
|
|
Colchicine With Azithromycin
Adverse Event
|
1
|
Baseline Characteristics
Drug-Drug Interaction Study of Colchicine and Azithromycin
Baseline characteristics by cohort
| Measure |
Colchicine Alone / With Azithromycin (at Steady State)
n=24 Participants
\[All subjects received each of the study treatments.\] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after 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
|
27.7 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 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
|
|
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
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 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
On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
|
Colchicine With Azithromycin (at Steady-state)
n=21 Participants
On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
2,737.00 pg/mL
Standard Deviation 1,136.28
|
3,051.76 pg/mL
Standard Deviation 1,206.72
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administrationThe area under the colchicine 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
On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
|
Colchicine With Azithromycin (at Steady-state)
n=21 Participants
On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
11,975.72 pg-hr/mL
Standard Deviation 5,485.83
|
17,161.00 pg-hr/mL
Standard Deviation 6,482.74
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administrationThe area under the colchicine 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
On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
|
Colchicine With Azithromycin (at Steady-state)
n=21 Participants
On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
14,125.25 pg-hr/mL
Standard Deviation 6,600.26
|
19,611.01 pg-hr/mL
Standard Deviation 7,678.56
|
Adverse Events
Colchicine Alone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Azithromycin Alone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Colchicine With Steady-state Azithromycin
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 7:30am after an overnight fast, followed by a washout period of 14 days.
|
Azithromycin Alone
n=22 participants at risk
On Day 15, each subject received two 250mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250mg azithromycin tablet daily at 07:30 without regard to meals on Days 16 to 18.
|
Colchicine With Steady-state Azithromycin
n=22 participants at risk
On Day 19, each subject received both one 0.6mg colchicine tablet and one 250mg azithromycin tablet at 07:30 after an overnight fast.
|
|---|---|---|---|
|
Cardiac disorders
cardiac flutter
|
0.00%
0/24
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
palpitations
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.00%
0/24
|
9.1%
2/22 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
diarrhoea
|
8.3%
2/24 • Number of events 2
|
0.00%
0/22
|
0.00%
0/22
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/24
|
0.00%
0/22
|
9.1%
2/22 • Number of events 3
|
|
Gastrointestinal disorders
stomach discomfort
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Gastrointestinal disorders
vomiting
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
back pain
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Gastrointestinal disorders
musculoskeletal stiffness
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Nervous system disorders
dizziness
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Nervous system disorders
headache
|
12.5%
3/24 • Number of events 4
|
9.1%
2/22 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
paraesthesia
|
0.00%
0/24
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
somnolence
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Nervous system disorders
syncope
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Psychiatric disorders
insomnia
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Renal and urinary disorders
pollakiuria
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60