UMIN-CTR Clinical Trial

Public title

An open-label, multiple oral dose study to explore the pharmacokinetic and pharmacodynamic profiles of 0.5mg colchicine in healthy male adult volunteers

Acronym

PK/ PD study of Colchicine-1

Scientific Title

An open-label, multiple oral dose study to explore the pharmacokinetic and pharmacodynamic profiles of 0.5mg colchicine in healthy male adult volunteers

Scientific Title:Acronym

PK/ PD study of Colchicine-1

Region

Japan

Condition

Coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yuji Kumagai

Organization

Kitasato University Hospital

Division name

Clinical Trial Center

Zip code

Address

1-15-1,Kitasato, Minami, Sagamihara, Kanagawa, 252-0375 Japan

TEL

+81-42-778-8111

Email

kuma-guy@za2.so-net.ne.jp

Name of contact person

1st name
Middle name
Last name	Mika Maeda

Organization

Kitasato University Hospital

Division name

Clinical Trial Center

Zip code

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

Institute

Clinical Trial Center, Kitasato University Hospital

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北里大学病院（神奈川県）

Date of disclosure of the study information

2015

Year

06

Month

23

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2015

Year

03

Month

26

Day

Date of IRB

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

Other related information

Registered date

2015

Year

06

Month

23

Day

Last modified on

2018

Year

12

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020898