PharmacokineticsPhase 4NCT01084278

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

A Phase 4 study testing Colchicine in people with Pharmacokinetics, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: Colchicine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: May 2010to Feb 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

West Coast Clinical Trials
Cypress, California, 90630

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Conditions: Pharmacokinetics
Being tested: Colchicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ColchicineDrug
Also called COLCRYS
Colchicine tablets

Study groups in NCT01084278
Study group	Role	What they receive
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. Receives: Drug: Colchicine
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. Receives: Drug: Colchicine
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. Receives: Drug: Colchicine
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. Receives: Drug: Colchicine
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. Receives: Drug: Colchicine

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax)
The maximum or peak concentration of colchicine in the plasma.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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-∞).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 15, post-dose during dialysis
Percentage of Colchicine Dose Recovered in Dialysate
The cumulative percentage of the colchicine dose recovered in dialysate.
Measured: Day 15, post-dose during dialysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Feb 2011

First posted10 Mar 2010 (estimated)
Study startMay 2010
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharmacokineticsStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01084278
Sponsor's protocol ID: MPC-004-09-1028
Other IDs: U1111-1132-3386
Status last verified: Sep 2012
First submitted: 8 Mar 2010
Last updated: 12 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease

All Pharmacokinetics trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01084278
Acronym / sponsor ID: MPC-004-09-1028
Conditions: Pharmacokinetics
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 10 Mar 2010 (estimated)
Results: Posted 12 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Healthy	Experimental	Drug: ColchicineHealthy 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	Drug: ColchicineParticipants 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	Drug: ColchicineParticipants 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	Drug: ColchicineParticipants 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	Drug: ColchicineParticipants 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ColchicineAlso: COLCRYSColchicine tablets	Drug	End stage renal disease (ESRD), Healthy, Mild renal impairment, Moderate renal impairment, Severe renal impairment

Primary outcome

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.

Results and safety

Results posted to the registry on 12 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy	8	8
Mild	8	8
Moderate	8	8
Severe	8	8
ESRD	8	8

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Healthy n = 8	Mild n = 8	Moderate n = 8	Severe n = 8	ESRD - Off Dialysis n = 8	ESRD - on Dialysis n = 8
Value	2.43 (0.68)	2.73 (0.78)	3.69 (1.42)	2.53 (0.73)	2.67 (0.94)	2.27 (0.71)

Population analysed: 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.

Primary outcome: 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. Mean (Standard Deviation). Unit: hours

Measure	Healthy n = 8	Mild n = 8	Moderate n = 8	Severe n = 8	ESRD - Off Dialysis n = 8	ESRD - on Dialysis n = 8
Value	1.31 (0.37)	1.01 (0.04)	1.31 (0.37)	1.58 (0.68)	1.31 (0.46)	1.29 (1.01)

Primary outcome: 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. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Healthy n = 8	Mild n = 8	Moderate n = 8	Severe n = 8	ESRD - Off Dialysis n = 8	ESRD - on Dialysis n = 8
Value	23.37 (7.75)	25.83 (5.43)	43.94 (11.68)	40.44 (13.58)	26.09 (8.73)	22.65 (8.54)

Primary outcome: 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.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Healthy n = 8	Mild n = 8	Moderate n = 8	Severe n = 8	ESRD - Off Dialysis n = 8	ESRD - on Dialysis n = 8
Value	24.73 (8.10)	27.21 (5.56)	48.94 (13.45)	48.00 (17.36)	31.68 (12.28)	30.61 (17.29)

Adverse events

Time frame: From the first dose of study drug up to 6 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
Mild	0 of 8 (0%)	2 of 8 (25%)	Not reported
Moderate	0 of 8 (0%)	4 of 8 (50%)	Not reported
Severe	0 of 8 (0%)	4 of 8 (50%)	Not reported
ESRD	0 of 8 (0%)	4 of 8 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pharmacokinetics

RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew Davis, MD study chair

Mutual Pharmaceutical Company, Inc.

Javier T Quesada, DO principal investigator

West Coast Clinical Trials, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Colchicine in people with Pharmacokinetics, run by Takeda at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01084278.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.