Pharmacokinetic Study With Colchicine in Healthy Volunteers

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT01017003

Run by

Mutual Pharmaceutical Company, Inc.

People needed

14

Starts

2007-09-01

Expected to finish

2007-12-01

Last updated by the study team

2009-11-20

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• PRACS Institute, Ltd. - Cetero Research — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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