Pharmacokinetic Study of an Acute Gout Regimen

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT01017042
First received: August 12, 2009
Last updated: October 5, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Pharmacokinetics
Drug: colchicine tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Open-Label Pharmacokinetic Study of a Low-Dose Acute Gout Regimen

Resource links provided by NLM:


Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Electrocardiogram Corrected QT Interval (QTcF) [ Time Frame: Measured at baseline, 0.5, 1, 2, and 4 hours ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: September 2007
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: colchicine
colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours)
Drug: colchicine tablets
colchicine 1.2mg initially; then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours)
Other Name: COLCRYS TM

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017042

Locations
United States, North Dakota
PRACS Institute, Ltd. - Cetero Research
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Mutual Pharmaceutical Company, Inc.
Investigators
Principal Investigator: Anthony R Godfrey, Pharm.D. PRACS Institiute, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Vice President, Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT01017042     History of Changes
Other Study ID Numbers: MPC-004-07-1003
Study First Received: August 12, 2009
Results First Received: August 12, 2009
Last Updated: October 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Mutual Pharmaceutical Company, Inc.:
healthy
blood levels

Additional relevant MeSH terms:
Colchicine
Antimitotic Agents
Antineoplastic Agents
Antirheumatic Agents
Gout Suppressants
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014