Pharmacokinetic Study With Colchicine in Healthy Volunteers

NCT01017003 | Completed Phase 1 Results

• 1 other identifier: MPC-004-07-1004
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pharmacokinetics

Keywords

healthy; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Maximum Serum Concentration (Cmax)

  maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions

  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

• Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.

  Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (t), calculated using the linear trapezoidal rule.

  0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing

• Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf)

  The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.

  0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing

Study Arms (2)

1

EXPERIMENTAL

0.6mg colchicine tablet

Drug: colchicine tablets

2

EXPERIMENTAL

colchicine 0.6mg q12 hours for 10 days

Drug: colchicine tablets

Interventions

colchicine tablets DRUG

0.6mg colchicine tablet

Also known as: COLCRYS TM

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Study Sites (1)

PRACS Institute, Ltd. - Cetero Research

Fargo, North Dakota, 58104, United States

Location

Related Links

• Recalls, Market Withdrawals and Safety Alerts
• Daily Med - Posting of Recently Submitted Labeling to the FDA

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Limitations and Caveats

14 subjects were sought, 13 enrolled due difficult recruitment. It was impossible to determine the kinetics of metabolites because none reached the level of detectability.

Results Point of Contact

• Title: Medical Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Study Officials

• Anthony R Godfrey, Pharm.D.

  PRACS Institiute, Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: November 20, 2009
• Study Start: September 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 20, 2009
• Results First Posted: November 20, 2009

Record last verified: 2009-10

Locations

US (1)