Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
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ClinicalTrials.gov Identifier: NCT01084278 |
Recruitment Status :
Completed
First Posted : March 10, 2010
Results First Posted : October 12, 2012
Last Update Posted : October 12, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pharmacokinetics | Drug: Colchicine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Single-Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Colcrys (Colchicine, USP) Tablets 0.6 mg Administered to Healthy Subjects and Subjects With Mild, Moderate, Severe Renal Impairment, and End-Stage Renal Disease |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | February 2011 |
Actual Study Completion Date : | February 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Healthy
Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
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Drug: Colchicine
Colchicine tablets
Other Name: COLCRYS |
Experimental: Mild renal impairment
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.
|
Drug: Colchicine
Colchicine tablets
Other Name: COLCRYS |
Experimental: Moderate renal impairment
Participants with moderate renal impairment (CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
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Drug: Colchicine
Colchicine tablets
Other Name: COLCRYS |
Experimental: Severe renal impairment
Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
Drug: Colchicine
Colchicine tablets
Other Name: COLCRYS |
Experimental: End stage renal disease (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.
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Drug: Colchicine
Colchicine tablets
Other Name: COLCRYS |
- 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 ]The maximum or peak concentration of colchicine in the plasma.
- 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 ]The time to reach the maximum or peak concentration of colchicine in the plasma.
- 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 ]The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration, calculated by the linear trapezoidal method.
- 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. ]The area under the plasma concentration versus time curve extrapolated to infinity. AUC 0 - ∞ is calculated as the sum of total AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
- 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. ]Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve for colchicine. The parameter was calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero plasma concentrations).
- 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. ]The apparent first-order terminal elimination half-life was calculated as 0.693/Kel.
- 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. ]The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel).
- 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. ]The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel), and normalized to body weight.
- 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. ]The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞).
- 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. ]The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞) and normalized to body weight (in kilograms).
- Amount of Colchicine Excreted in Urine (Ae[0-t]) [ Time Frame: Pre-dose on Day 1 and up to 120 hours post dose. ]The amount of colchicine excreted in urine during the post-dose collection, calculated as the sum of the amounts in the individual collection intervals (Ae).
- 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. ]The cumulative percentage of the colchicine dose excreted in urine up to the final collection time, calculated as Ae(0-t) × 100/dose
- Renal Clearance of Colchicine (CLR) [ Time Frame: Pre-dose on Day 1 and up to 120 hours post dose. ]Renal clearance of colchicine, calculated as Ae(0 t)/AUC 0-t.
- Dialysis Clearance of Colchicine (CLD) [ Time Frame: Day 15, post-dose during dialysis ]The dialysis clearance of colchicine, calculated as amount of colchicine recovered in dialysate / AUCt2-t1 where t1 and t2 are the times of the start and end of hemodialysis.
- Percentage of Colchicine Dose Recovered in Dialysate [ Time Frame: Day 15, post-dose during dialysis ]The cumulative percentage of the colchicine dose recovered in dialysate.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Adult males and females 18-70 years old with a body mass index of <39 kg/m^2.
- Patients with normal renal function or mild renal impairment should be generally healthy on the basis of medical history and physical exam.
- Patients with moderate to end stage renal impairment should be generally medically healthy other than with respect to the morbidities associated with impaired renal function.
- Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures).
Exclusion Criteria:
- Known hypersensitivity to colchicine or any component of the formulation of the study drug.
- Patients with a history or presence of a significant medical condition that would interfere with interpretation of the study results.
- Patients who have used any drugs or substances known to inhibit or induce cytochrome P450 (CYP) enzymes and/or P-glycoprotein within 28 days prior to the first dose and throughout the study.
- Patients with recent (2 year) history or evidence of alcoholism or drug abuse or significant psychiatric disease.
- Patients with chronic hepatic dysfunction.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084278
United States, California | |
West Coast Clinical Trials | |
Cypress, California, United States, 90630 |
Study Chair: | Matthew Davis, MD | Mutual Pharmaceutical Company, Inc. | |
Principal Investigator: | Javier T Quesada, DO | West Coast Clinical Trials, LLC |
Responsible Party: | Takeda |
ClinicalTrials.gov Identifier: | NCT01084278 History of Changes |
Other Study ID Numbers: |
MPC-004-09-1028 U1111-1132-3386 ( Registry Identifier: WHO ) |
First Posted: | March 10, 2010 Key Record Dates |
Results First Posted: | October 12, 2012 |
Last Update Posted: | October 12, 2012 |
Last Verified: | September 2012 |
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