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Trial record 91 of 372 for:    under | North Dakota, United States

Drug-Drug Interaction Study Between Colchicine and Cyclosporine

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ClinicalTrials.gov Identifier: NCT00983931
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
Conditions Pharmacokinetics
Healthy
Interventions Drug: Colchicine
Drug: Cyclosporine
Enrollment 24
Recruitment Details Twenty-four (24) healthy, non-smoking, male and female volunteers, consisting of volunteers from the community at large, were enrolled in the study.
Pre-assignment Details 41 subjects were screened, 11 were screen failures, 4 had schedule conflicts, 1 was transferred to a different study, and 1 was not needed
Arm/Group Title Colchicine Alone / With Cyclosporine
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, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine 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
Physician Decision             1
[1]
one subject withdrawn due to creatine kinase out of range
Period Title: Colchicine With Cyclosporine
Started 23
Completed 23
Not Completed 0
Arm/Group Title Colchicine Alone / With Cyclosporine
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, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine 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
0
   0.0%
Between 18 and 65 years
24
 100.0%
>=65 years
0
   0.0%
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
29.0  (6.9)
[1]
Measure Description: age range: >=18 and <=45 years old
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
14
  58.3%
Male
10
  41.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
1
   4.2%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
23
  95.8%
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
0
   0.0%
Not Hispanic or Latino
24
 100.0%
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 colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Alone Colchicine With Cyclosporine
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, followed by a washout period of 14 days.
On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: pg/mL
2,720.04  (1,137.85) 8,817.48  (2,223.80)
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 colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Alone Colchicine With Cyclosporine
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, followed by a washout period of 14 days.
On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: pg-hr/mL
12,545.04  (5,854.46) 39,828.11  (10,312.85)
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 colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Alone Colchicine With Cyclosporine
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, followed by a washout period of 14 days.
On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: pg-hr/mL
14,996.79  (7,789.77) 47,312.02  (12,137.79)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Colchicine Alone Colchicine With Cyclosporine
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, followed by a washout period of 14 days. On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
All-Cause Mortality
Colchicine Alone Colchicine With Cyclosporine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Colchicine Alone Colchicine With Cyclosporine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/23 (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 Colchicine With Cyclosporine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4      4    
Gastrointestinal disorders     
abdominal pain upper  1  0/24 (0.00%)  0 1/23 (4.35%)  1
nausea  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Infections and infestations     
bacteriuria  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Injury, poisoning and procedural complications     
contusion  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Nervous system disorders     
dizziness  1  1/24 (4.17%)  1 0/23 (0.00%)  0
headache  1  1/24 (4.17%)  1 3/23 (13.04%)  3
Respiratory, thoracic and mediastinal disorders     
cough  1  0/24 (0.00%)  0 1/23 (4.35%)  1
pharynolaryngeal pain  1  1/24 (4.17%)  1 0/23 (0.00%)  0
throat irritation  1  0/24 (0.00%)  0 1/23 (4.35%)  1
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: NCT00983931     History of Changes
Other Study ID Numbers: MPC-004-08-1016
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