Drug-Drug Interaction Study of Colchicine and Clarithromycin

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00984061
First received: August 13, 2009
Last updated: October 5, 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: Pharmacokinetics
Interventions: Drug: colchicine
Drug: clarithromycin

  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 members 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
56 subjects screened, 32 were screen failures

Reporting Groups
  Description
Colchicine Alone / With Clarithromycin [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.

Participant Flow for 4 periods

Period 1:   Colchicine Alone
    Colchicine Alone / With Clarithromycin  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 2:   21 Day Washout Period
    Colchicine Alone / With Clarithromycin  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 3:   Clarithromycin Alone
    Colchicine Alone / With Clarithromycin  
STARTED     24  
COMPLETED     23 [1]
NOT COMPLETED     1  
Protocol Violation                 1  
[1] One subject was dropped due to noncompliance with outpatient clarithromycin regimen.

Period 4:   Colchicine With Clarithromycin
    Colchicine Alone / With Clarithromycin  
STARTED     23  
COMPLETED     23  
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 Clarithromycin [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.

Baseline Measures
    Colchicine Alone / With Clarithromycin  
Number of Participants  
[units: participants]
  24  
Age [1]
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     24  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  22.3  ± 4.1  
Gender  
[units: participants]
 
Female     13  
Male     11  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     24  
Region of Enrollment  
[units: participants]
 
United States     24  
[1] age range: >=18 and <=45 years old



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

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

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


  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: NCT00984061     History of Changes
Other Study ID Numbers: MPC-004-07-1006
Study First Received: August 13, 2009
Results First Received: August 13, 2009
Last Updated: October 5, 2009
Health Authority: United States: Food and Drug Administration