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Drug-Drug Interaction Study of Colchicine and Clarithromycin

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ClinicalTrials.gov Identifier: NCT00984061
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 Pharmacokinetics
Interventions Drug: colchicine
Drug: clarithromycin
Enrollment 24
Recruitment Details Twenty-four (24) healthy, non-smoking, adult male and female volunteers, consisting of members of the community at large, were enrolled.
Pre-assignment Details 56 subjects screened, 32 were screen failures
Arm/Group Title Colchicine Alone / With Clarithromycin
Hide Arm/Group Description [All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
Period Title: Colchicine Alone
Started 24
Completed 24
Not Completed 0
Period Title: 21 Day Washout Period
Started 24
Completed 24
Not Completed 0
Period Title: Clarithromycin Alone
Started 24
Completed 23 [1]
Not Completed 1
Reason Not Completed
Protocol Violation             1
[1]
One subject was dropped due to noncompliance with outpatient clarithromycin regimen.
Period Title: Colchicine With Clarithromycin
Started 23
Completed 23
Not Completed 0
Arm/Group Title Colchicine Alone / With Clarithromycin
Hide Arm/Group Description [All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 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   [1] 
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%
[1]
Measure Description: age range: >=18 and <=45 years old
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
22.3  (4.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
13
  54.2%
Male
11
  45.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 24 participants
24
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 collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Alone Colchicine With Clarithromycin
Hide Arm/Group Description:
Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.84  (0.88) 8.44  (1.49)
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 colchicine 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.
Time Frame serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Alone Colchicine With Clarithromycin
Hide Arm/Group Description:
Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
12.37  (4.66) 41.95  (9.78)
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 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.
Time Frame serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Alone Colchicine With Clarithromycin
Hide Arm/Group Description:
Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
15.53  (7.70) 52.62  (12.02)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Colchicine Alone Clarithromycin Alone Colchicine With Clarithromycin
Hide Arm/Group Description On the morning of Day 1 after a fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg. On the evening of Day 22, subjects began taking (on an outpatient basis) one tablet of clarithromycin 250 mg every 12 hours for 7 days without regard to meals. On the morning of Day 29 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with the last dose of clarithromycin.
All-Cause Mortality
Colchicine Alone Clarithromycin Alone Colchicine With Clarithromycin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Colchicine Alone Clarithromycin Alone Colchicine With Clarithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/23 (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 Clarithromycin Alone Colchicine With Clarithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7      5      4    
Ear and labyrinth disorders       
hypoacusis * 1  1/24 (4.17%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Gastrointestinal disorders       
abdominal pain upper * 1  0/24 (0.00%)  0 1/23 (4.35%)  1 0/23 (0.00%)  0
diarrhea * 1  0/24 (0.00%)  0 0/23 (0.00%)  0 2/23 (8.70%)  2
nausea * 1  2/24 (8.33%)  2 0/23 (0.00%)  0 2/23 (8.70%)  2
stomach discomfort * 1  0/24 (0.00%)  0 1/23 (4.35%)  1 0/23 (0.00%)  0
General disorders       
chest pain * 1  0/24 (0.00%)  0 0/23 (0.00%)  0 1/23 (4.35%)  1
vessel puncture site hematoma * 1  1/24 (4.17%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Injury, poisoning and procedural complications       
skin laceration * 1  1/24 (4.17%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders       
pain in extremity * 1  2/24 (8.33%)  2 1/23 (4.35%)  2 0/23 (0.00%)  0
Nervous system disorders       
dizziness * 1  1/24 (4.17%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
headache * 1  3/24 (12.50%)  4 2/23 (8.70%)  2 2/23 (8.70%)  2
syncope * 1  2/24 (8.33%)  2 0/23 (0.00%)  0 0/23 (0.00%)  0
vision blurred * 1  1/24 (4.17%)  2 0/23 (0.00%)  0 1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders       
cough * 1  0/24 (0.00%)  0 1/23 (4.35%)  1 0/23 (0.00%)  0
epistaxis * 1  1/24 (4.17%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
pharyngolaryngeal pain * 1  0/24 (0.00%)  0 1/23 (4.35%)  1 0/23 (0.00%)  0
sinus congestion * 1  1/24 (4.17%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Vascular disorders       
pallor * 1  2/24 (8.33%)  2 0/23 (0.00%)  0 0/23 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA SOC
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Mutual Pharmaceutical Company, Inc.
Phone: 215-697-1743
EMail: clinicaltrials@urlmutual.com
Layout table for additonal information
Responsible Party: Vice President Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00984061     History of Changes
Other Study ID Numbers: MPC-004-07-1006
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