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Pharmacokinetic Study With Colchicine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT01017003
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
Intervention: Drug: colchicine tablets

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Colchicine - Single Dose, Twice Daily Dose, Final Single Dose 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.

Participant Flow for 4 periods

Period 1:   Single Dose Colchicine 0.6 mg, Day 1
    Colchicine - Single Dose, Twice Daily Dose, Final Single Dose  
STARTED     13  
COMPLETED     13  
NOT COMPLETED     0  

Period 2:   14 Day Washout Period
    Colchicine - Single Dose, Twice Daily Dose, Final Single Dose  
STARTED     13  
COMPLETED     13  
NOT COMPLETED     0  

Period 3:   Colchicine 0.6 mg Twice Daily x 10 Days
    Colchicine - Single Dose, Twice Daily Dose, Final Single Dose  
STARTED     13  
COMPLETED     13  
NOT COMPLETED     0  

Period 4:   Colchicine 0.6 mg Final Dose
    Colchicine - Single Dose, Twice Daily Dose, Final Single Dose  
STARTED     13  
COMPLETED     13  
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 - Single Dose, Twice Daily Dose, Final Single Dose 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.

Baseline Measures
    Colchicine - Single Dose, Twice Daily Dose, Final Single Dose  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     0  
Age  
[units: years]
Mean ( Full Range )
  25.5  
  ( 19 to 38 )  
Gender  
[units: participants]
 
Female     1  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     13  



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

2.  Primary:   Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.   [ 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 ]

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


  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
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.


  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


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
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