Coronary artery disease
Conditions
Interventions
0.5mg Colchicine orally once a day in morning for 7days
Sponsors
Clinical Trial Center, Kitasato University Hospital
Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus School of Medicine Department of Pharmacy, University of the Ryukyus Hospital Cardiology, Fukuoka University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects have to fulfill all of following inclusion/exclusion criteria and be judged eligibility by the investigator. 1 Willingness and ability to communicate and comply with all study requirements. Written informed consent to participate in the study prior to any study procedures. 2 Male subjects aged 20years or older and younger than 40when written informed consent is obtained. 3 Subjects must be 50kg or more and less than 100kg in weight and 18kg/m2 or more and less than 27kg/m2 in BMI 4 Subjects must be judged as eligible by the investigator after examining the history tailing, physical examinations and laboratory tests. 5 Subjects whose partners are of child-bearing potential and had not been taken vasectomy to avoid pregnancy must agree to conduct contraception during the study and 90 days after the last dose of the investigational drug.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inhibition of FFA-induced leukocyte activation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMika Maeda
Kitasato University Hospital Clinical Trial Center
Outcome results
None listed