Pharmacokinetic Study With Colchicine in Healthy Volunteers

NCT ID: NCT01017003

Last Updated: 2009-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-12-31

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.

Detailed Description

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.

Conditions

Pharmacokinetics

Keywords

healthy; pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

0.6mg colchicine tablet

Group Type: EXPERIMENTAL

colchicine tablets

Intervention Type: DRUG

0.6mg colchicine tablet

2

colchicine 0.6mg q12 hours for 10 days

Group Type: EXPERIMENTAL

colchicine tablets

Intervention Type: DRUG

0.6mg q12 hours for 10 days

Interventions

colchicine tablets

0.6mg colchicine tablet

Intervention Type: DRUG

colchicine tablets

0.6mg q12 hours for 10 days

Intervention Type: DRUG

Other Intervention Names

COLCRYS TM; COLCRYS TM

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mutual Pharmaceutical Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Mutual Pharmaceutical Company, Inc.

Principal Investigators

Anthony R Godfrey, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

PRACS Institiute, Ltd.

Locations

PRACS Institute, Ltd. - Cetero Research

Fargo, North Dakota, United States

Countries

United States

Related Links

http://www.fda.gov/opacom/7alerts.html

Recalls, Market Withdrawals and Safety Alerts

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Daily Med - Posting of Recently Submitted Labeling to the FDA

Other Identifiers

MPC-004-07-1004

Identifier Type: -

Identifier Source: org_study_id