At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Colchicine +1 moredrug
Likely dose
Colchicine 0.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Double-Dummy Pharmacokinetic and Exploratory Electrocardiogram (ECG) Safety Study of a Standard Acute Gout Regimen
In Brief
A Phase 1 clinical trial evaluating Colchicine and Moxifloxacin for Pharmacokinetics. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
Primary CompletionDec 2007
Study CompletionJan 2008
First PostedNov 2009
TodayJul 2026
First PostedNov 23, 2009
Enrollment StartNov 1, 2007
Primary CompletionDec 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.6 years ago
Interventions
Colchicinedrug
two 0.6 mg capsules (1.2 mg dose) followed by an additional 0.6mg capsule every hour for 6 additional doses
Moxifloxacindrug
400 mg capsule at the 6 hour point