CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
colchicine +2 moredrug
Likely dose
colchicine 0.6mgfrom 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.

Search/NCT00984061
NCT00984061Phase 1Completed
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A Pharmacokinetic Study to Evaluate the Effect of Clarithromycin on the Pharmacokinetic Profile of Colchicine in Healthy Adults

Mutual Pharmaceutical Company, Inc.·interventional·Posted Sep 24, 2009·Updated Oct 15, 2009

In Brief

A Phase 1 clinical trial evaluating colchicine and clarithromycin for Pharmacokinetics. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is responsible for the efflux of colchicine across membranes. This study will evaluate the effect of clarithromycin-related inhibition of CYP 3A4 and P-gp on the pharmacokinetics of colchicine. It will also evaluate the safety and tolerability of concurrent administration of clarithromycin and a single dose of colchicine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2009
Enrollment StartNov 1, 2007
Primary CompletionDec 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.8 years ago

Interventions

colchicinedrug

0.6mg tablet administered at 9am on Day 1

clarithromycindrug

250 mg clarithromycin tablet taken on an outpatient basis twice daily at 8am and 8pm for 14 doses (starting with 8pm dose on Day 22 and concluding with 8am dose on Day 29)

colchicinedrug

0.6 mg tablet administered at 9am on Day 29