drugset / Trial / NCT01018420

Pharmacokinetic and Exploratory Electrocardiogram (ECG) Study

NCT01018420

Phase 1 Completed 18 enrolled Mutual Pharmaceutical Company, Inc.
RandomizedParallel-groupQuadruple-blindBasic science

Summary

This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen of 4.8 mg over 6 hours. In addition it will compare the electrocardiogram (ECG) changes, if any, from this dosing regimen to that of a single dose of moxifloxacin 400 mg, a positive control for the corrected QT interval (QTc) prolongation.

Timeline

Start
2007-11
Primary completion
2007-12
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.6 mg Oral
Comparator Moxifloxacin Small molecule 400 mg

Indications

No indication recorded.