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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1132-3386 | Registry Identifier | WHO |
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The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal function, in patients with mild, moderate or severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An additional objective of this study is to study the clearance of colchicine and its metabolites by hemodialysis. Secondary objectives include evaluation of the safety and tolerability of colchicine in the study population.
40 male and female subjects will be enrolled in the study and stratified into one of five groups based on their renal status as determined from creatinine clearance (CrCL) estimated using the serum creatinine (sCR) and the Cockcroft-Gault and Modified Diet in Renal Disease (MDRD) equations as follows: Treatment group 1 - healthy adults with normal renal function (CrCL/eGFR> 90 mL/min); Treatment groups 2, 3 and 4 - patients with mild (CrCL/eGFR 60-89 mL/min), moderate (CrCL/eGFR 30 to 59 mL/min), and severe (CrCL/eGFR 15 to 29 mL/min) renal impairment, respectively; and Treatment group 5 - subjects with end-stage renal disease requiring hemodialysis. On study day 1, participants in Treatment Groups 1 to 4 will be administered one colchicine 0.6 mg tablet at 8 a.m. under standard fasting conditions. Blood samples will be collected from all participants before dosing and both blood and urine samples will be collected for 120 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of colchicine and its primary metabolites. There will be two study periods for treatment group 5; Period 1 off dialysis and Period 2 on dialysis with a 14 day washout period between the two study periods. On study day 1, participants in treatment group 5 will be administered one colchicine 0.6 mg tablet under standard fasting conditions immediately following dialysis. Blood samples will be collected from all participants before dosing and for up to 70 hours post-dose at times sufficient to adequately determine the pharmacokinetics of colchicine and its primary metabolites. All adverse events will be evaluated by the investigator and reported in the participant's case report form.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Experimental | Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1. |
|
| Mild renal impairment | Experimental | 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 renal impairment | Experimental | Participants with moderate renal impairment (CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1. |
|
| Severe renal impairment | Experimental | Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1. |
|
| End stage renal disease (ESRD) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | The maximum or peak concentration of colchicine in the plasma. | 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 |
| Time to Maximum Plasma Concentration (Tmax) | The time to reach the maximum or peak concentration of colchicine in the plasma. | 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 |
| Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (AUC 0-t) | 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. | 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 |
| Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0 - ∞) | 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. | 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 (Kel) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Davis, MD | Mutual Pharmaceutical Company, Inc. | Study Chair |
| Javier T Quesada, DO | West Coast Clinical Trials, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials | Cypress | California | 90630 | United States |
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.
Participants took part in the study at three investigative sites in the United States from 25 May 2010 to 28 February 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy | Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1. |
| FG001 | 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. |
| FG002 | Moderate | Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1. |
| FG003 | Severe | Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy | Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) | The maximum or peak concentration of colchicine in the plasma. | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
|
| 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 Half-life (t½) | The apparent first-order terminal elimination half-life was calculated as 0.693/Kel. | 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 (V-area/F) | The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel). | 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. |
| Weight-adjusted Apparent Total Volume of Distribution After Administration (V-area/F) | The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel), and normalized to body weight. | 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 Total Body Clearance of Colchicine | The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞). | 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. |
| Weight-adjusted Apparent Total Body Clearance of Colchicine | The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞) and normalized to body weight (in kilograms). | 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. |
| Amount of Colchicine Excreted in Urine (Ae[0-t]) | 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). | Pre-dose on Day 1 and up to 120 hours post dose. |
| Percentage of Colchicine Dose Excreted in Urine up to the Final Collection Time | The cumulative percentage of the colchicine dose excreted in urine up to the final collection time, calculated as Ae(0-t) × 100/dose | Pre-dose on Day 1 and up to 120 hours post dose. |
| Renal Clearance of Colchicine (CLR) | Renal clearance of colchicine, calculated as Ae(0 t)/AUC 0-t. | Pre-dose on Day 1 and up to 120 hours post dose. |
| Dialysis Clearance of Colchicine (CLD) | 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. | Day 15, post-dose during dialysis |
| Percentage of Colchicine Dose Recovered in Dialysate | The cumulative percentage of the colchicine dose recovered in dialysate. | Day 15, post-dose during dialysis |
| BG002 | Moderate | Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1. |
| BG003 | Severe | Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Child Bearing Potential | Counts are based on the number of female participants. | Number | participants |
|
| Creatinine Clearance/estimated Glomerular Filtration Rate | Creatinine Clearance for Healthy Treatment Group and estimated Glomerular Filtration Rate for Mild, Moderate, Severe and ESRD Treatment Groups. | Mean | Standard Deviation | mL/min |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Mild |
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1. |
| OG002 | Moderate | Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1. |
| OG003 | Severe | Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1. |
| OG004 | ESRD - Off Dialysis | Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis. |
| OG005 | ESRD - on Dialysis | Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis. |
|
|
| Primary | Time to Maximum Plasma Concentration (Tmax) | The time to reach the maximum or peak concentration of colchicine in the plasma. | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | hours | 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 |
|
|
|
| Primary | Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (AUC 0-t) | 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. | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | ng*h/mL | 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 |
|
|
|
| Primary | Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0 - ∞) | 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. | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | ng*h/mL | 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. |
|
|
|
| Primary | Apparent First-order Terminal Elimination Rate Constant (Kel) | 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). | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | 1/hr | 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. |
|
|
|
| Primary | Apparent First-order Terminal Elimination Half-life (t½) | The apparent first-order terminal elimination half-life was calculated as 0.693/Kel. | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | hr | 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. |
|
|
|
| Primary | The Apparent Total Volume of Distribution After Administration (V-area/F) | The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel). | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | L | 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. |
|
|
|
| Primary | Weight-adjusted Apparent Total Volume of Distribution After Administration (V-area/F) | The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel), and normalized to body weight. | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | L/kg | 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. |
|
|
|
| Primary | Apparent Total Body Clearance of Colchicine | The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞). | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | L/hr | 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. |
|
|
|
| Primary | Weight-adjusted Apparent Total Body Clearance of Colchicine | The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞) and normalized to body weight (in kilograms). | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | L/hr/kg | 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. |
|
|
|
| Primary | Amount of Colchicine Excreted in Urine (Ae[0-t]) | 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). | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | mg | Pre-dose on Day 1 and up to 120 hours post dose. |
|
|
|
| Primary | Percentage of Colchicine Dose Excreted in Urine up to the Final Collection Time | The cumulative percentage of the colchicine dose excreted in urine up to the final collection time, calculated as Ae(0-t) × 100/dose | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | percent of dose | Pre-dose on Day 1 and up to 120 hours post dose. |
|
|
|
| Primary | Renal Clearance of Colchicine (CLR) | Renal clearance of colchicine, calculated as Ae(0 t)/AUC 0-t. | Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis. | Posted | Mean | Standard Deviation | L/hr | Pre-dose on Day 1 and up to 120 hours post dose. |
|
|
|
| Primary | Dialysis Clearance of Colchicine (CLD) | 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. | ESRD participants on dialysis, where data were available. | Posted | Mean | Standard Deviation | L/h | Day 15, post-dose during dialysis |
|
|
|
| Primary | Percentage of Colchicine Dose Recovered in Dialysate | The cumulative percentage of the colchicine dose recovered in dialysate. | ESRD participants on dialysis, where data were available. | Posted | Mean | Standard Deviation | percent dose | Day 15, post-dose during dialysis |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | 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. | 0 | 8 | 2 | 8 |
| EG002 | Moderate | Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1. | 0 | 8 | 4 | 8 |
| EG003 | Severe | Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1. | 0 | 8 | 4 | 8 |
| EG004 | 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. | 0 | 8 | 4 | 8 |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Infusion site induration | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
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.