UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open-label, multiple oral dose study to explore the pharmacokinetic and pharmacodynamic profiles of 0.5mg colchicine in healthy male adult volunteers
Title of the study (Brief title)	PK/ PD study of Colchicine-1
Region	Japan

Condition
Condition	Coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore relationship between the pharmacokinetics and pharmacodynamics of Colchicine after oral multiple-dose administration in healthy male volunteers
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Inhibition of FFA-induced leukocyte activation
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	0.5mg Colchicine orally once a day in morning for 7days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male
Key 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.
Key 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
Target sample size	8

Research contact person
Name of lead principal investigator	Yuji Kumagai
Organization	Kitasato University Hospital
Division name	Clinical Trial Center
Address	1-15-1,Kitasato, Minami, Sagamihara, Kanagawa, 252-0375 Japan
TEL	+81-42-778-8111
Email	kuma-guy@za2.so-net.ne.jp

Public contact
Name of contact person	Mika Maeda
Organization	Kitasato University Hospital
Division name	Clinical Trial Center
Address	1-15-1,Kitasato, Minami, Sagamihara, Kanagawa, 252-0375 Japan
TEL	+81-42-778-8242
Homepage URL
Email	m-maeda@kitasato-u.ac.jp

Sponsor
Institute	Clinical Trial Center, Kitasato University Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	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
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 23 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 26 Day
Anticipated trial start date	2015 Year 04 Month 28 Day
Last follow-up date	2015 Year 07 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 23 Day
Last modified on	2018 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020898