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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000678
Receipt No. 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

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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
Institute Zeria Pharmaceutical Co., LTD.
Institute
Department

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
URL(English) https://upload.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


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