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Pharmacokinetic Study of an Acute Gout Regimen

Information source: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics

Intervention: colchicine tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mutual Pharmaceutical Company, Inc.

Official(s) and/or principal investigator(s):
Anthony R Godfrey, Pharm.D., Principal Investigator, Affiliation: PRACS Institiute, Ltd.

Summary

This study aims to characterize the pharmacokinetic profile of colchicine after a regimen of 1. 8 mg over two hours. A secondary goal is to evaluate the safety and tolerability of this regimen in healthy volunteers. To this end, all study subjects will be monitored for adverse effects throughout the entire study period.

Clinical Details

Official title: Open-Label Pharmacokinetic Study of a Low-Dose Acute Gout Regimen

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Maximum Plasma Concentration

Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (96 Hours) (AUC 0-t)

Area Under The Concentration Time Curve From Zero Through Infinity (AUC∞)

Secondary outcome: Electrocardiogram Corrected QT Interval (QTcF)

Detailed description: This study aims to characterize the pharmacokinetic profile of colchicine and its three main metabolites, after a regimen of 1. 8 mg over two hours. After a fast of at least 10 hours, fifteen healthy non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 55 will be given colchicine 1. 2 mg (2 x 0. 6 mg) orally followed by an additional single 0. 6mg dose one hour later. Fasting will continue for 4 hours after the first dose at which time a standardized meal will be served. Blood will be drawn from all participants at times sufficient to adequately define the pharmacokinetics of colchicine and its 3 major metabolites, 2, 3 and 10 demethylcolchicine. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. To this end, subjects will be monitored throughout participation in the study for adverse reactions to the study drug and/or procedures. Seated and standing blood pressure and pulse will be measured prior to the first dose and 0. 5, 1, 2, 4, and 12 hours post-dose. Twelve-lead electrocardiograms will be obtained at the same time points. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy adults 18-55 years of age, non smoking and non-pregnant (postmenopausal,

surgically sterile or using effective contraceptive measures) weighing at least 55kg and within 15% of ideal body weight. Exclusion Criteria:

- Recent participation (within 30 days) in other research studies

- Recent significant blood donation

- 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

- 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

Locations and Contacts

PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota 58104, United States
Additional Information

Recalls, Market Withdrawals and Safety Alerts

Daily Med - Posting of Recently Submitted Labeling to the FDA

Starting date: September 2007
Last updated: October 5, 2009

Page last updated: August 20, 2015

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