Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01084278
First received: March 8, 2010
Last updated: September 11, 2012
Last verified: September 2012
Results First Received: September 11, 2012  
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

  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
Participants took part in the study at three investigative sites in the United States from 25 May 2010 to 28 February 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Healthy participants, participants with mild, moderate or severe renal impairment and participants with end stage renal disease (requiring hemodialysis) were stratified to one of five treatment groups based on their renal status. All participants received 0.6 mg colchicine.

Reporting Groups
  Description
Healthy Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
Mild Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
Moderate Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
Severe Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
ESRD Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.

Participant Flow:   Overall Study
    Healthy     Mild     Moderate     Severe     ESRD  
STARTED     8     8     8     8     8  
COMPLETED     8     8     8     8     8  
NOT COMPLETED     0     0     0     0     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
Healthy Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
Mild Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
Moderate Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
Severe Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
ESRD Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
Total Total of all reporting groups

Baseline Measures
    Healthy     Mild     Moderate     Severe     ESRD     Total  
Number of Participants  
[units: participants]
  8     8     8     8     8     40  
Age  
[units: years]
Mean ± Standard Deviation
  52.5  ± 5.29     63.9  ± 3.94     63.0  ± 5.4     57.6  ± 8.48     42.2  ± 12.85     55.85  ± 10.96  
Gender  
[units: participants]
           
Female     4     4     4     4     4     20  
Male     4     4     4     4     4     20  
Race/Ethnicity, Customized  
[units: participants]
           
American Indian or Alaska Native     0     0     1     0     0     1  
Asian     0     2     0     0     0     2  
Black or African American     0     0     3     3     6     12  
Native Hawaiian or other pacific islander     0     0     0     0     0     0  
White     8     6     4     4     2     24  
Other     0     0     0     1     0     1  
Race/Ethnicity, Customized  
[units: participants]
           
Hispanic or Latino     5     3     3     1     0     12  
Not Hispanic or Latino     3     5     5     7     8     28  
Region of Enrollment  
[units: participants]
           
United States     8     8     8     8     8     40  
Child Bearing Potential [1]
[units: participants]
           
Yes     0     0     1     0     2     3  
No     4     4     3     4     2     17  
Creatinine Clearance/estimated Glomerular Filtration Rate [2]
[units: mL/min]
Mean ± Standard Deviation
  111.49  ± 22.651     73.3  ± 8.10     40.0  ± 6.78     22  ± 4.17     10.9  ± 2.97     55.70  ± 36.61  
Height  
[units: cm]
Mean ± Standard Deviation
  170.33  ± 7.722     167.94  ± 8.865     164.83  ± 9.054     172.06  ± 8.643     168.05  ± 11.991     169.09  ± 9.27  
Weight  
[units: kg]
Mean ± Standard Deviation
  77.09  ± 8.494     65.55  ± 9.904     77.55  ± 10.667     100.81  ± 16.856     73.86  ± 22.287     78.95  ± 18.47  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  26.54  ± 2.113     23.18  ± 2.560     28.64  ± 4.823     33.96  ± 4.489     25.66  ± 5.018     27.60  ± 5.28  
[1] Counts are based on the number of female participants.
[2] Creatinine Clearance for Healthy Treatment Group and estimated Glomerular Filtration Rate for Mild, Moderate, Severe and ESRD Treatment Groups.



  Outcome Measures
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1.  Primary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose ]

2.  Primary:   Time to Maximum Plasma Concentration (Tmax)   [ Time Frame: Day 1 and Day 15 (for ESRD patients only) at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose ]

3.  Primary:   Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (AUC 0-t)   [ Time Frame: Day 1 and Day 15 (ESRD patients only), predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose ]

4.  Primary:   Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0 - ∞)   [ Time Frame: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose. ]

5.  Primary:   Apparent First-order Terminal Elimination Rate Constant (Kel)   [ Time Frame: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose. ]

6.  Primary:   Apparent First-order Terminal Elimination Half-life (t½)   [ Time Frame: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose. ]

7.  Primary:   The Apparent Total Volume of Distribution After Administration (V-area/F)   [ Time Frame: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose. ]

8.  Primary:   Weight-adjusted Apparent Total Volume of Distribution After Administration (V-area/F)   [ Time Frame: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose. ]

9.  Primary:   Apparent Total Body Clearance of Colchicine   [ Time Frame: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose. ]

10.  Primary:   Weight-adjusted Apparent Total Body Clearance of Colchicine   [ Time Frame: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose. ]

11.  Primary:   Amount of Colchicine Excreted in Urine (Ae[0-t])   [ Time Frame: Pre-dose on Day 1 and up to 120 hours post dose. ]

12.  Primary:   Percentage of Colchicine Dose Excreted in Urine up to the Final Collection Time   [ Time Frame: Pre-dose on Day 1 and up to 120 hours post dose. ]

13.  Primary:   Renal Clearance of Colchicine (CLR)   [ Time Frame: Pre-dose on Day 1 and up to 120 hours post dose. ]

14.  Primary:   Dialysis Clearance of Colchicine (CLD)   [ Time Frame: Day 15, post-dose during dialysis ]

15.  Primary:   Percentage of Colchicine Dose Recovered in Dialysate   [ Time Frame: Day 15, post-dose during dialysis ]


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01084278     History of Changes
Other Study ID Numbers: MPC-004-09-1028, U1111-1132-3386
Study First Received: March 8, 2010
Results First Received: September 11, 2012
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration