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Trial record 92 of 371 for:    under | North Dakota, United States

Drug-Drug Interaction Study Between Colchicine and Diltiazem ER

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ClinicalTrials.gov Identifier: NCT00983372
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : September 24, 2009
Last Update Posted : October 15, 2009
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy; Adult; Volunteer; Colchicine; Pharmacokinetics; Diltiazem; Cytochrome p450 3A4; P-glycoprotein
Interventions Drug: Colchicine
Drug: Diltiazem ER
Enrollment 24
Recruitment Details Twenty-four (24) healthy, non-smoking , male and female volunteers, consisting of members of the community at large, were enrolled in the study.
Pre-assignment Details 53 subjects were screened, 13 were screen failures, 14 had schedule conflicts, 1 transferred to a different study, and 1 was not needed
Arm/Group Title Colchicine Alone / With Diltiazem (at Steady-state)
Hide Arm/Group Description [All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
Period Title: Colchicine Alone
Started 24
Completed 24
Not Completed 0
Period Title: 14 Day Washout Period
Started 24
Completed 23 [1]
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
subject withdrew consent due to schedule conflict - during washout period or diltiazem alone
Period Title: Diltiazem ER Alone
Started 23
Completed 20 [1]
Not Completed 3
Reason Not Completed
missed diltiazem dose             2
Adverse Event             1
[1]
two subjects dropped due to missed diltiazem ER dose; one subject dropped due to vomitting
Period Title: Colchicine With Diltiazem ER
Started 20
Completed 20
Not Completed 0
Arm/Group Title Colchicine Alone / With Diltiazem (at Steady-state)
Hide Arm/Group Description [All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
1
   4.2%
Between 18 and 65 years
23
  95.8%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
28.0  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
9
  37.5%
Male
15
  62.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
2
   8.3%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   4.2%
Black or African American
3
  12.5%
White
18
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
1
   4.2%
Not Hispanic or Latino
23
  95.8%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description The maximum or peak concentration that colchicine reaches in the plasma.
Time Frame serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Alone Colchicine With Diltiazem (at Steady-state)
Hide Arm/Group Description:
Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: pg/mL
2,172.32  (868.72) 2,802.90  (1,245.01)
2.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
Hide Description The area under the 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.
Time Frame serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Alone Colchicine With Diltiazem (at Steady-state)
Hide Arm/Group Description:
Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: pg-hr/mL
10,035.57  (4,562.57) 17,729.64  (8,642.59)
3.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
Hide Description 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.
Time Frame serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Alone Colchicine With Diltiazem (at Steady-state)
Hide Arm/Group Description:
Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: pg-hr/mL
12,025.69  (5,418.95) 22,485.97  (10,994.16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Colchicine Alone Diltiazem Alone Colchicine With Steady-state Diltiazem
Hide Arm/Group Description Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. On Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
All-Cause Mortality
Colchicine Alone Diltiazem Alone Colchicine With Steady-state Diltiazem
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Colchicine Alone Diltiazem Alone Colchicine With Steady-state Diltiazem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/21 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Colchicine Alone Diltiazem Alone Colchicine With Steady-state Diltiazem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6      9      4    
Eye disorders       
dry eye  1  1/24 (4.17%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
eye irritation  1  1/24 (4.17%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Gastrointestinal disorders       
dyspepsia  1  0/24 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
nausea  1  1/24 (4.17%)  1 1/21 (4.76%)  1 1/20 (5.00%)  1
vomiting  1  0/24 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
General disorders       
chest pain  1  1/24 (4.17%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders       
musculoskeletal pain  1  1/24 (4.17%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders       
dizziness  1  0/24 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
headache  1  2/24 (8.33%)  2 8/21 (38.10%)  11 3/20 (15.00%)  3
lethargy  1  0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders       
pharyngolaryngeal pain  1  1/24 (4.17%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
rhinorrhea  1  0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  2
Skin and subcutaneous tissue disorders       
contact dermatitis  1  0/24 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical Director
Organization: Mutual Pharmaceutical Company, Inc.
Phone: 215-697-1743
Responsible Party: Vice President, Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00983372     History of Changes
Other Study ID Numbers: MPC-004-08-1015
First Submitted: August 13, 2009
First Posted: September 24, 2009
Results First Submitted: August 13, 2009
Results First Posted: September 24, 2009
Last Update Posted: October 15, 2009