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

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.

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.