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Drug-Drug Interaction Study of Colchicine and Clarithromycin

NCT00984061 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-10-15

Study results available
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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.

Conditions

  • Pharmacokinetics

Interventions

DRUG

colchicine

0.6mg tablet administered at 9am on Day 1

DRUG

clarithromycin

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)

DRUG

colchicine

0.6 mg tablet administered at 9am on Day 29

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Matthew Davis, MD · Mutual Pharmaceutical Company, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2007-12-31
Completion
2008-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00984061 on ClinicalTrials.gov