UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000678
Receipt number R000000815
Scientific Title Clinical Pharmacology Study of Z-206 - Study on Drug Concentration in Mucous Membrane of Z-206 in Healthy Male Adults-
Date of disclosure of the study information 2007/04/13
Last modified on 2009/04/28 17:11:58

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Basic information

Public title

Clinical Pharmacology Study of Z-206 -
Study on Drug Concentration in Mucous Membrane of Z-206 in Healthy Male Adults-

Acronym

Clinical Pharmacology Study of Z-206 -Study on Drug Concentration in Mucous Membrane of Z-206 in Healthy Male Adults-

Scientific Title

Clinical Pharmacology Study of Z-206 -
Study on Drug Concentration in Mucous Membrane of Z-206 in Healthy Male Adults-

Scientific Title:Acronym

Clinical Pharmacology Study of Z-206 -Study on Drug Concentration in Mucous Membrane of Z-206 in Healthy Male Adults-

Region

Japan


Condition

Condition

Ulcerative Colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

With healthy male adults as subjects, the drug concentration in the mucous membrane of the large intestines is examined when Z-206 is repeatedly administered at dose of 1.2g/day, 2.4 g/day or 3.6g/day. In addition, the drug concentration in plasma of these subjects is examined.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

The drug concentration in the mucous membrane of the large intestines

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Z-206 1.2g/day group: One Z-206 400mg tablet and 2 Z-206 placebo tablets per time (total 3 tablets). Three times a day (t.i.d.) after each meal for total of 19 administrations. In the morning of day 3, day 5 and day 7 of administration, it is to be taken under fasting condition.

Interventions/Control_2

Z-206 2.4g/day group: Two Z-206 400mg tablets and 1 Z-206 placebo tablet per time (total 3 tablets). Three times a day (t.i.d.) after each meal for total of 19 administrations. In the morning of day 3, day 5 and day 7 of administration, it is to be taken under fasting condition.

Interventions/Control_3

Z-206 3.6g/day group: Three Z-206 400mg tablets per time. Three times a day (t.i.d.) after each meal for total of 19 administrations. In the morning of day 3, day 5 and day 7 of administration, it is to be taken under fasting condition.

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

50 years-old >

Gender

Male

Key inclusion criteria

1)Healthy male adults whose age is 20 years or older but less than 50 years old at the time of obtaining informed consent and whose BMI values are 17.6 to 26.4
2)Subjects who can understand the contents of this trial and can give consents in writing to participate in this trial

Key exclusion criteria

1)Subjects with hypersensitivity to drugs, drug dependency, or alcohol dependency or history of such
2)Subjects currently suffering from impediments of the digestive organs, disorders of the liver, renal disorders, hematological disorders, circulatory system diseases, mental or nervous disorders, etc., which are considered to be inappropriate for the participation in trial or history of such
3)Subjects with HBs antigen, HCV antibody, HIV antigen antibody, and positive syphilis serum test
4)Subjects taking a drug(s) within 1 week of the administration of the trial drug
5)Subjects receiving administration of any trial drug within 4 months prior to the trial drug administration
6)Subjects who received whole blood collection of 200 mL within 1 month before the trial drug administration or component blood collection within 2 weeks or blood collection of 400 mL or more (such as blood donation) within 3 months
7)Others, subjects judged by the principal investigator or co-investigators to be inappropriate for participation in this drug trial

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Ito

Organization

Kitano Hospital

Division name

Division of Intestinal and Inflammatory Bowel Disease

Zip code


Address

2-4-20, Ohgimachi, Kita-ku, Osaka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Zeria Pharmaceutical Co., LTD.

Organization

Zeria Pharmaceutical Co., LTD.

Division name

Clinical Research

Zip code


Address

10-11, Nihonbashi, Kobuna-cho, Chuo-ku, Tokyo, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Zeria Pharmaceutical Co., LTD.

Institute

Department

Personal name



Funding Source

Organization

Zeria Pharmaceutical Co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2007 Year 04 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2007 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2007 Year 04 Month 01 Day

Last follow-up date

2007 Year 09 Month 01 Day

Date of closure to data entry

2007 Year 09 Month 01 Day

Date trial data considered complete

2007 Year 09 Month 01 Day

Date analysis concluded

2008 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 04 Month 13 Day

Last modified on

2009 Year 04 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000815


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name