A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00984009
First received: August 13, 2009
Last updated: November 11, 2011
Last verified: November 2011
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
Other: Grapefruit Juice

  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-two (22) healthy, non-smoking, non-obese, adult, 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
46 subjects screened, 13 were screen failures, 6 had schedule conflicts or were no shows for check-in, 1 was not screened per request of study site, 2 were transferred to a different study

Reporting Groups
  Description
Colchicine Alone / With Grapefruit Juice [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, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.

Participant Flow for 4 periods

Period 1:   Colchicine Alone
    Colchicine Alone / With Grapefruit Juice  
STARTED     22  
COMPLETED     22  
NOT COMPLETED     0  

Period 2:   14 Day Washout Period
    Colchicine Alone / With Grapefruit Juice  
STARTED     22  
COMPLETED     22  
NOT COMPLETED     0  

Period 3:   Grapefruit Juice Alone
    Colchicine Alone / With Grapefruit Juice  
STARTED     22  
COMPLETED     21 [1]
NOT COMPLETED     1  
missed serving of grapefruit juice                 1  
[1] one subject dropped due to missed a.m. serving of grapefruit juice on Day 16

Period 4:   Colchicine With Grapefruit Juice
    Colchicine Alone / With Grapefruit Juice  
STARTED     21  
COMPLETED     21  
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 Grapefruit Juice [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, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.

Baseline Measures
    Colchicine Alone / With Grapefruit Juice  
Number of Participants  
[units: participants]
  22  
Age, Customized [1]
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     22  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  26.9  ± 6.9  
Gender  
[units: participants]
 
Female     6  
Male     16  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     22  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     20  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     22  
[1] age range: ≥18 and ≤45



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine 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 colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine 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 colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration ]


  Serious Adverse Events


  Other Adverse Events


  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 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: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00984009     History of Changes
Other Study ID Numbers: MPC-004-08-1017
Study First Received: August 13, 2009
Results First Received: August 13, 2009
Last Updated: November 11, 2011
Health Authority: United States: Food and Drug Administration