UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007162 |
|---|---|
| Receipt number | R000008420 |
| Scientific Title | Pharmacodynamics(PD) study of Arbekacin Sulfate in Epithelial Lining Fluid (ELF), an open-label study. |
| Date of disclosure of the study information | 2012/01/31 |
| Last modified on | 2016/01/10 22:07:18 |
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Basic information
Public title
Pharmacodynamics(PD) study of Arbekacin Sulfate in Epithelial Lining Fluid (ELF), an open-label study.
Acronym
PD study of Arbekacin Sulfate in ELF
Scientific Title
Pharmacodynamics(PD) study of Arbekacin Sulfate in Epithelial Lining Fluid (ELF), an open-label study.
Scientific Title:Acronym
PD study of Arbekacin Sulfate in ELF
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate PK and lung translatability of Arbekacin Sulfate in ELF by Bronchoscopic Micro-sampling(BMS) analysis on healthy volunteers.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate PK in plasma and ELF of Arbekacin Sulfate, the ratio ELF:plasma of Arbekacin Sulfate.
Key secondary outcomes
none
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
intravenous drip of arbekacin sulfate
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers except exclusion criteria and abnormalities proved by the pre-medical test. With informed consent as volunteers.
Key exclusion criteria
1) History of hypersensitivity caused by aminoglycoside antibiotics or bacitracin.
2) One who has family or patient's history of hearing loss caused by aminoglycoside antibiotics. One who has hearing loss caused by any other reasons.
3)In medication.
4)Creatinine clearance and less than 30mL/min.
5)Smorker.
6)Any other participants whose condition is inappropriate for the evaluation of this clinical study, judged by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hasegawa |
Organization
Keio University Hospital
Division name
Center for Infectious Diseases and Infection Control,
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
TEL
03-3353-3710
n-hasegawa@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Funatsu |
Organization
Keio University Hospital
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
TEL
03-5363-3793
Homepage URL
dodeko81@ybb.ne.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Meiji Seika Pharma
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
none
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.jiac-j.com/article/S1341-321X(14)00215-3/abstract
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
| 2010 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 01 | Day |
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 | 30 | Day |
Last modified on
| 2016 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008420
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
