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Pharmacokinetic Study With Colchicine in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01017003
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : November 20, 2009
Last Update Posted : November 20, 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
Intervention Drug: colchicine tablets
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Colchicine - Single Dose, Twice Daily Dose, Final Single Dose
Hide Arm/Group Description All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
Period Title: Single Dose Colchicine 0.6 mg, Day 1
Started 13
Completed 13
Not Completed 0
Period Title: 14 Day Washout Period
Started 13
Completed 13
Not Completed 0
Period Title: Colchicine 0.6 mg Twice Daily x 10 Days
Started 13
Completed 13
Not Completed 0
Period Title: Colchicine 0.6 mg Final Dose
Started 13
Completed 13
Not Completed 0
Arm/Group Title Colchicine - Single Dose, Twice Daily Dose, Final Single Dose
Hide Arm/Group Description All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
25.5
(19 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
1
   7.7%
Male
12
  92.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Maximum Serum Concentration (Cmax)
Hide Description maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions
Time Frame Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Colchicine Pharmacokinetics (Day 1) Colchicine Pharmacokinetics at Steady State (Day 25)
Hide Arm/Group Description:
0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
2450.15  (702.11) 3553.15  (843.45)
2.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.
Hide Description Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (t), calculated using the linear trapezoidal rule.
Time Frame 0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
by protocol
Arm/Group Title Colchicine Pharmacokinetics (Day 1) Colchicine Pharmacokinetics at Steady State (Day 25)
Hide Arm/Group Description:
0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg-h/ml
10494.66  (3544.08) 43576.96  (9333.26)
3.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf)
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 plasma concentration to the elimination rate constant.
Time Frame 0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
by protocol
Arm/Group Title Colchicine Pharmacokinetics (Day 1) Colchicine Pharmacokinetics at Steady State (Day 25)
Hide Arm/Group Description:
0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: pg-h/ml
12268.18  (4422.08) 54198.77  (9214.54)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Colchicine Pharmacokinetics (Day 1) Colchicine Pharmacokinetics at Steady State (Day 25)
Hide Arm/Group Description 0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1) 0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
All-Cause Mortality
Colchicine Pharmacokinetics (Day 1) Colchicine Pharmacokinetics at Steady State (Day 25)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Colchicine Pharmacokinetics (Day 1) Colchicine Pharmacokinetics at Steady State (Day 25)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (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 Pharmacokinetics (Day 1) Colchicine Pharmacokinetics at Steady State (Day 25)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0      4    
Gastrointestinal disorders     
Diarrhea  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Dry Mouth  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Stomach Discomfort  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Metabolism and nutrition disorders     
Decreased Appetite  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders     
Muscle Spasms  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Nervous system disorders     
Dizziness  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
14 subjects were sought, 13 enrolled due difficult recruitment. It was impossible to determine the kinetics of metabolites because none reached the level of detectability.
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: NCT01017003     History of Changes
Other Study ID Numbers: MPC-004-07-1004
First Submitted: August 13, 2009
First Posted: November 20, 2009
Results First Submitted: August 13, 2009
Results First Posted: November 20, 2009
Last Update Posted: November 20, 2009