Trial Outcomes & Findings for Drug-Drug Interaction Between Colchicine and Verapamil ER (NCT NCT00983242)
NCT ID: NCT00983242
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
On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.
Results posted on
2009-10-15
Participant Flow
Twenty-four (24) healthy, non-smoking, adult male and female volunteers consisting of the community at large were enrolled.
Forty-four (44) subjects were screened, thirteen (13) were screen failures, five (5) were transferred to a different study, one (1) did not appear at check in at Period 1 and one (1) was not needed for the study.
Participant milestones
| Measure |
Colchicine Alone, Colchicine With Verapamil HCl ER
All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
|
|---|---|
|
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
|
|
Verapamil HCl ER Alone
STARTED
|
24
|
|
Verapamil HCl ER Alone
COMPLETED
|
24
|
|
Verapamil HCl ER Alone
NOT COMPLETED
|
0
|
|
Colchicine With Verapamil HCl ER
STARTED
|
24
|
|
Colchicine With Verapamil HCl ER
COMPLETED
|
24
|
|
Colchicine With Verapamil HCl ER
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug-Drug Interaction Between Colchicine and Verapamil ER
Baseline characteristics by cohort
| Measure |
Colchicine Alone, Colchicine With Verapamil HCl ER
n=24 Participants
All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
|
|---|---|
|
Age, Customized
<=18 years
|
2 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
22 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=5 Participants
|
|
Age Continuous
|
27.75 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 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: On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.The maximum or peak concentration that colchicine reaches in the plasma.
Outcome measures
| Measure |
Colchicine Alone
n=24 Participants
At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
|
Colchicine With Verapamil HCl ER
n=24 Participants
At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
2,968.42 pg/mL
Standard Deviation 1,259.63
|
3,850.63 pg/mL
Standard Deviation 1,458.96
|
PRIMARY outcome
Timeframe: On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable colchicine concentration (time t), as calculated by the linear trapezoidal method.
Outcome measures
| Measure |
Colchicine Alone
n=24 Participants
At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
|
Colchicine With Verapamil HCl ER
n=24 Participants
At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
13,085.26 pg-hr/mL
Standard Deviation 5,292.05
|
24,637.91 pg-hr/mL
Standard Deviation 6,556.67
|
PRIMARY outcome
Timeframe: On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.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 colchicine plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Colchicine Alone
n=24 Participants
At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
|
Colchicine With Verapamil HCl ER
n=24 Participants
At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
15,371.17 pg-hr/mL
Standard Deviation 6,311.09
|
30,586.33 pg-hr/mL
Standard Deviation 8,283.83
|
Adverse Events
Colchicine Alone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Verapamil HCl ER
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Colchicine With Verapamil HCl ER
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Colchicine Alone
n=24 participants at risk
At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
|
Verapamil HCl ER
n=24 participants at risk
At 8am on Days 15-18 all subjects received a dose of verapamil HCl ER 240 mg without regard to meals.
|
Colchicine With Verapamil HCl ER
n=24 participants at risk
At 8am on Day 19 following a 10 hour fast all subjects received one dose of verapamil HCl ER 240 mg along with one dose of colchicine 0.6 mg.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Feeling hot
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Number of events 3
|
33.3%
8/24 • Number of events 13
|
16.7%
4/24 • Number of events 5
|
|
Nervous system disorders
Sinus congestion
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
Additional Information
Medical Affairs Director
Mutual Pharmaceutical Company, Inc.
Phone: 215-697-1743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60