Pharmacokinetic and Exploratory Electrocardiogram (ECG) Study

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT01018420

Run by

Mutual Pharmaceutical Company, Inc.

People needed

18

Starts

2007-11-01

Expected to finish

2008-01-01

Last updated by the study team

2009-12-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults 18-55 years of age, non smoking and non-pregnant, weighing at least 55kg and within 15% of ideal body weight, with no significant EKG changes

You may not qualify if…

• Pregnant or lactating
• Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
• Recent (2-year) history or evidence of alcoholism or drug abuse
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
• History or family history of congenital long QT syndrome (LQTS) or sudden death possibly related to LQTS
• Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 30 days prior to the first dose and throughout the study

Where it is running

• PRACS Institute, Ltd. - Cetero Research — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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