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Completed

NCT Number: NCT01017042

Pharmacokinetic Study of an Acute Gout Regimen

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRACS Institute, Ltd. - Cetero Research

Fargo, North Dakota, 58104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine Tablets

Drug

colchicine 1.2mg initially; then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours)

Other names: COLCRYS TM

Primary outcomes

  1. Maximum Plasma Concentration

    Time frame: Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).

    The maximum or peak concentration that the drug reaches in the plasma.

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

    Time frame: Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).

    The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration (96hours), calculated by the linear trapezoidal rule.

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

    Time frame: Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).

    The area under the plasma concentration versus time curve extrapolated to infinity.

    AUC∞ is calculated as the sum of Total AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant

Secondary outcomes

  1. Electrocardiogram Corrected QT Interval (QTcF)

    Time frame: Measured at baseline, 0.5, 1, 2, and 4 hours

    Corrected QT interval by Fridericia's formula -Measured at baseline, 0.5, 1, 2, and 4 hours

Sponsors and collaborators

Lead sponsor

Mutual Pharmaceutical Company, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Nov 20, 2009
Registry last updated
Nov 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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