An open-label, multiple oral dose study to explore the pharmacokinetic and pharmacodynamic profiles of 0.5mg colchicine in healthy male adult volunteers
- Conditions
- Coronary artery disease
- Registration Number
- JPRN-UMIN000018042
- Lead Sponsor
- Clinical Trial Center, Kitasato University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 8
Not provided
Subjects will be excluded from the study by the following criteria. The investigator must ensure the criteria basically at the screening visit. 1 Subjects who have history of hypersensitivity to Colchicine, Heparin and Fat emulsion 2 Subjects who are contraindicated to the use of Colchicine, Heparin and Fat emulsion 3 Subjects with haptic and renal dysfunction that needs any treatments 4 Subjects with diseases or conditions that are assumed to be adversely affected by pharmacological effects of Colchicine, Heparin and Fat emulsion 5 Subjects took any drug or health food containing St Johns wort within 7 days before dosing and be judged not eligible for the enrollment of the study by the investigator 6 Subjects who took food and drink containing grapefruits 7 days prior to dosing 7 Subjects who participated any clinical trials within 3 months before the enrollment 8 Subjects who donated 200ml of blood within a month or 400ml within 3 months 9 Subjects who showed positive results of Syphilis test, Hepatitis B surface antigen or Hepatitis C 10 Subjects who had history of drug or alcohol abuse or who showed evidence of such abuse by the laboratory test at the screening 11 Subjects whom the investigator consider ineligible for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Inhibition of FFA-induced leukocyte activation
- Secondary Outcome Measures
Name Time Method 1. Concentrations of Colchicine in plasma and leukocytes (polymorphonuclear and mononuclear cells) 2.Plasma concentrations of cytokines and myeloperoxidase released from activated leukocytes 3. Analysis of the protein expression levels of leukocytes inflammatory signals 4. Production of angiotensin II in polymorphonuclear and mononuclear cells 5. Relationship between pharmacokinetics and pharmacodynamics of Colchicine