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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Takeda
• Treatments: Colchicine

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.