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
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
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
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
