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drugset / Trial / NCT01084278

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

NCT01084278 ↗

Phase 4 Completed 40 enrolled Takeda
Non-randomizedSingle-groupOpen-labelBasic science

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.

Timeline

Start
2010-05
Primary completion
2011-02
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.6 mg Oral

Indications

No indication recorded.