Pharmacokinetic Study With Colchicine in Healthy Volunteers

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mutual Pharmaceutical Company, Inc.
• Treatments: Colchicine

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