Phase 4 N=40 Basic Science

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

Pharmacokinetics

Bottom Line

View on ClinicalTrials.gov: NCT01084278 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcome: Primary: Maximum Plasma Concentration (Cmax) — 2.43; 2.73; 3.69; 2.53 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Colchicine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Takeda
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Plasma Concentration (Cmax)	2.43; 2.73; 3.69; 2.53; 2.67; 2.27	—
PRIMARY Time to Maximum Plasma Concentration (Tmax)	1.31; 1.01; 1.31; 1.58; 1.31; 1.29	—
PRIMARY Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (AUC 0-t)	23.37; 25.83; 43.94; 40.44; 26.09; 22.65	—
PRIMARY Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0 - ∞)	24.73; 27.21; 48.94; 48.00; 31.68; 30.61	—
PRIMARY Apparent First-order Terminal Elimination Rate Constant (Kel)	0.023; 0.023; 0.018; 0.014; 0.025; 0.020	—
PRIMARY Apparent First-order Terminal Elimination Half-life (t½)	30.63; 30.92; 39.90; 49.53; 29.38; 40.80	—
PRIMARY The Apparent Total Volume of Distribution After Administration (V-area/F)	1131.68; 1024.22; 761.81; 1009.02; 870.46; 1263.0	—
PRIMARY Weight-adjusted Apparent Total Volume of Distribution After Administration (V-area/F)	14.84; 15.80; 10.06; 9.91; 13.35; 18.91	—
PRIMARY Apparent Total Body Clearance of Colchicine	26.34; 23.04; 13.63; 14.59; 22.07; 25.78	—
PRIMARY Weight-adjusted Apparent Total Body Clearance of Colchicine	0.34; 0.36; 0.18; 0.14; 0.35; 0.41	—
PRIMARY Amount of Colchicine Excreted in Urine (Ae[0-t])	0.110; 0.100; 0.094; 0.058	—
PRIMARY Percentage of Colchicine Dose Excreted in Urine up to the Final Collection Time	18.34; 16.69; 15.67; 9.63	—
PRIMARY Renal Clearance of Colchicine (CLR)	4.78; 3.90; 2.12; 1.69	—
PRIMARY Dialysis Clearance of Colchicine (CLD)	7.4	—
PRIMARY Percentage of Colchicine Dose Recovered in Dialysate	5.2	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01084278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.