UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007025 |
|---|---|
| Receipt number | R000008288 |
| Scientific Title | A clinical cassette microdose study of aromatase inhibitors |
| Date of disclosure of the study information | 2012/01/06 |
| Last modified on | 2012/03/14 21:04:55 |
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Basic information
Public title
A clinical cassette microdose study of aromatase inhibitors
Acronym
A clinical cassette microdose study of aromatase inhibitors
Scientific Title
A clinical cassette microdose study of aromatase inhibitors
Scientific Title:Acronym
A clinical cassette microdose study of aromatase inhibitors
Region
| Japan |
Condition
Condition
The breast cancer metastasized to the brain
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of human pharmacokinetics of Cetrozole and TMD-322 at an early stage of drug development
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma pharmacokinetics of Cetrozole, TMD-322 and anastrozole
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cassette-dosing study drug (Cetrozole and TMD-322)
Interventions/Control_2
Anastrozole
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
1) Healthy male volunteers who are equal or more than 20-year-old and less than 40 year-old when informed consent is obtained
2) Body mass index (BMI) is between 18.0 and 30.0
3) Volunteers enable to agree to make contraception during the study and one month after the final dosing of study drugs
4) A written informed consent is obtained by volunteers after being informed of this study, which is perfomed before the enrollment.
Key exclusion criteria
1) Volunteers who have present and/or past history of disease of heart and circulatory system, liver, kidney and ureteral system, digestive system, and blood system
2) Volunteers who have present and/or past history of drug and alcohol addiction and drug allergy
3) Volunteers who is taking medicines which will affect the result of this study
4) Volunteers who had any medicines within 7 days before taking study drugs
5) Volunteers who takes health food product like St.John's wort and/or fruit juice including grape fruit juice within 7 days before taking study drugs
6) Volunteers who joined other clinical study within 3 months before this study
7) Volunteers who donated blood before this study such as:
(a) >200 mL within a month
(b) >400 mL within 3 months
8) Volunteers who is positive for serological reaction of syphilis, HIV antibody, HBs antigen, HCV antibody
9) Others: Volunteers who are diagnosed by medical doctors as unsuitable for joining this study
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takashima |
Organization
Osaka City University Hospital
Division name
Department of Surgical Oncology
Zip code
Address
1-5-7 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisako Fujii |
Organization
Osaka City University Hospital
Division name
Center for Drug & Food Clinical Evaluation
Zip code
Address
TEL
06-6645-3443
Homepage URL
hfujii@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
New Energy and Industrial Technology Development Organization (NEDO)
Organization
Division
Category of Funding 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
| 2012 | Year | 01 | Month | 06 | 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
| 2011 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 06 | Day |
Last modified on
| 2012 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008288
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
