Pharmacokinetic Study With Colchicine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT01017003
First received: August 13, 2009
Last updated: October 5, 2009
Last verified: October 2009

August 13, 2009
October 5, 2009
September 2007
October 2007   (final data collection date for primary outcome measure)
  • Maximum Serum Concentration (Cmax) [ Time Frame: Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing ] [ Designated as safety issue: No ]
  • Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level. [ Time Frame: 0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing ] [ Designated as safety issue: No ]
  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf) [ Time Frame: 0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01017003 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Study With Colchicine in Healthy Volunteers
An Open Label, Two Period, Sequential, Single Dose and Multiple Dose Pharmacokinetic Study With 0.6mg Colchicine Tablets in Healthy Volunteers

This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.

This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers. After a fast of at least 10 hours, fourteen healthy non-smoking, non-obese, non-pregnant volunteers will receive a single oral dose of colchicine 0.6 mg. Fasting will continue for 4 hours after the dose, at which time a standard meal will be served. Blood will be drawn from all participants at times sufficient to adequately define the single dose pharmacokinetics of colchicine and its 3 major metabolites, 2, 3 and 10 demethylcolchicine. Following a 14 day washout period, all participants will begin a 10 day regimen of colchicine 0.6 mg orally every 12 hours. On the morning of day 25, after a fast of at least 10 hours, all participants will receive their final dose of colchicine 0.6 mg. Again blood will be drawn at times sufficient to determine the pharmacokinetics of colchicine and its 3 major metabolites after chronic dosing. The pharmacokinetic parameters for each dosing situation will be derived and compared for relevant differences. Though not a specific goal of this study, all participants will be monitored for adverse events by observation and query during periods of confinement on days 1, 15 and 25, as well as by complete blood count (CBC) with differential and clinical chemistry, sitting and standing blood pressures, and heart rate and 12-lead electrocardiogram (EKG) before and after dosing, on days 1 and 25.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Pharmacokinetics
  • Drug: colchicine tablets
    0.6mg colchicine tablet
    Other Name: COLCRYS TM
  • Drug: colchicine tablets
    0.6mg q12 hours for 10 days
    Other Name: COLCRYS TM
  • Experimental: 1
    0.6mg colchicine tablet
    Intervention: Drug: colchicine tablets
  • Experimental: 2
    colchicine 0.6mg q12 hours for 10 days
    Intervention: Drug: colchicine tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of the screening process within 28 days prior to Period I dosing
  • Healthy non-smoking, non-obese adult men and women volunteers between the ages of 18 to 45 years of age, weighing at least 110 with a body mass index of 18-30kg/m2
  • Women must be postmenopausal, surgically sterile, commit to abstinence from heterosexual sexual contact or use two methods of contraception.

Exclusion Criteria:

  • Pregnant or lactating
  • Use of any investigational drug within 28 days prior to Period I dosing.
  • Presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s)
  • Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
  • Clinical laboratory test values outside the accepted reference range and when confirmed on re-examination.
  • Any clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators)
  • Use of any systemic prescription medication in the 14 days prior to Period I dosing
  • History of any allergy(s) including allergy to colchicine or related drugs.
  • History of drug or alcohol addiction or abuse within the past year or a positive drug abuse screen
  • Currently or recent (within 6 months) use of tobacco products prior to dose administration
  • Donation of greater than 150 mL of blood within 28 days or plasma within 14 days prior to period I dosing
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01017003
MPC-004-07-1004
No
Vice President Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
Mutual Pharmaceutical Company, Inc.
Not Provided
Principal Investigator: Anthony R Godfrey, Pharm.D. PRACS Institiute, Ltd.
Mutual Pharmaceutical Company, Inc.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP