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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Takeda Global Research & Development Center, Inc.

ClinicalTrials.gov Identifier:

NCT01084278

First received: March 8, 2010

Last updated: September 11, 2012

Last verified: September 2012

History of Changes

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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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 ]

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

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 ]

Show Outcome Measure 3

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. ]

Show Outcome Measure 4

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. ]

Show Outcome Measure 5

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. ]

Show Outcome Measure 6

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. ]

Show Outcome Measure 7

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. ]

Show Outcome Measure 8

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. ]

Show Outcome Measure 9

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. ]

Show Outcome Measure 10

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. ]

Show Outcome Measure 11

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. ]

Show Outcome Measure 12

13. Primary:

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

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14. Primary:

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

Show Outcome Measure 14

15. Primary:

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

Show Outcome Measure 15

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No publication related to study results will be made without Sponsor’s prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.

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 Global Research & Development Center, Inc.
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

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