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Drug-Drug Interaction Between Colchicine and Verapamil ER

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00983242
First received: August 13, 2009
Last updated: October 12, 2009
Last verified: October 2009
History of Changes
Results First Received: August 13, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Pharmacokinetics
Interventions: Drug: Colchicine
Drug: Verapamil HCl ER

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty-four (24) healthy, non-smoking, adult male and female volunteers consisting of the community at large were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow for 4 periods

 Period 1:   Colchicine Alone
    Colchicine Alone, Colchicine With Verapamil HCl ER  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 2:   14 Day Washout Period
    Colchicine Alone, Colchicine With Verapamil HCl ER  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 3:   Verapamil HCl ER Alone
    Colchicine Alone, Colchicine With Verapamil HCl ER  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 4:   Colchicine With Verapamil HCl ER
    Colchicine Alone, Colchicine With Verapamil HCl ER  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
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.

Baseline Measures
    Colchicine Alone, Colchicine With Verapamil HCl ER  
Number of Participants  
[units: participants]
 		  24  
Age, Customized [1]
[units: participants]
 		 
<=18 years     2  
Between 18 and 65 years     22  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  27.75  ± 9.15  
Gender  
[units: participants]
 		 
Female     18  
Male     6  
Ethnicity (NIH/OMB)  
[units: paricipants]
 		 
Hispanic or Latino     1  
Not Hispanic or Latino     23  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 		 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     23  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 		 
United States     24  
[1] >=18 and <=45



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: 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. ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Maximum Plasma Concentration (Cmax)
Measure Description The maximum or peak concentration that colchicine reaches in the plasma.
Time Frame 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Colchicine Alone 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 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.

Measured Values
    Colchicine Alone     Colchicine With Verapamil HCl ER  
Number of Participants Analyzed  
[units: participants]
 		  24     24  
Maximum Plasma Concentration (Cmax)  
[units: pg/mL]
Mean ± Standard Deviation 		  2,968.42  ± 1,259.63     3,850.63  ± 1,458.96  

No statistical analysis provided for Maximum Plasma Concentration (Cmax)



2.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]   [ Time Frame: 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. ]
  Show Outcome Measure 2

3.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]   [ Time Frame: 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. ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Affairs Director
Organization: Mutual Pharmaceutical Company, Inc.
phone: 215-697-1743
e-mail: clinicaltrials@urlpharma.com


No publications provided by Mutual Pharmaceutical Company, Inc.

Publications automatically indexed to this study:


Responsible Party: Vice President, Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00983242     History of Changes
Other Study ID Numbers: MPC-004-08-1014
Study First Received: August 13, 2009
Results First Received: August 13, 2009
Last Updated: October 12, 2009
Health Authority: United States: Food and Drug Administration