Drug-Drug Interaction Study Between Colchicine and Diltiazem ER

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00983372
First received: August 13, 2009
Last updated: October 12, 2009
Last verified: October 2009
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: Healthy; Adult; Volunteer; Colchicine; Pharmacokinetics; Diltiazem; Cytochrome p450 3A4; P-glycoprotein
Interventions: Drug: Colchicine
Drug: Diltiazem 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 , male and female volunteers, consisting of members of the community at large, were enrolled in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
53 subjects were screened, 13 were screen failures, 14 had schedule conflicts, 1 transferred to a different study, and 1 was not needed

Reporting Groups
  Description
Colchicine Alone / With Diltiazem (at Steady-state) [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.

Participant Flow for 4 periods

Period 1:   Colchicine Alone
    Colchicine Alone / With Diltiazem (at Steady-state)  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 2:   14 Day Washout Period
    Colchicine Alone / With Diltiazem (at Steady-state)  
STARTED     24  
COMPLETED     23 [1]
NOT COMPLETED     1  
Withdrawal by Subject                 1  
[1] subject withdrew consent due to schedule conflict - during washout period or diltiazem alone

Period 3:   Diltiazem ER Alone
    Colchicine Alone / With Diltiazem (at Steady-state)  
STARTED     23  
COMPLETED     20 [1]
NOT COMPLETED     3  
missed diltiazem dose                 2  
Adverse Event                 1  
[1] two subjects dropped due to missed diltiazem ER dose; one subject dropped due to vomitting

Period 4:   Colchicine With Diltiazem ER
    Colchicine Alone / With Diltiazem (at Steady-state)  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     0  



  Baseline Characteristics
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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 / With Diltiazem (at Steady-state) [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.

Baseline Measures
    Colchicine Alone / With Diltiazem (at Steady-state)  
Number of Participants  
[units: participants]
  24  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     23  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.0  ± 8.0  
Gender  
[units: participants]
 
Female     9  
Male     15  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     2  
Asian     0  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     3  
White     18  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     23  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     24  



  Outcome Measures
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1.  Primary:   Maximum Plasma Concentration (Cmax)   [ 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 ]

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Mutual Pharmaceutical Company, Inc.
phone: 215-697-1743
e-mail: clinicaltrials@urlmutual.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: NCT00983372     History of Changes
Other Study ID Numbers: MPC-004-08-1015
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