UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012895 |
|---|---|
| Receipt number | R000015066 |
| Scientific Title | Investigation on bronchoalveolar lavage technique as an evaluation of drug migration to lung tissue |
| Date of disclosure of the study information | 2014/01/18 |
| Last modified on | 2014/02/06 15:58:45 |
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Basic information
Public title
Investigation on bronchoalveolar lavage technique as an evaluation of drug migration to lung tissue
Acronym
Investigation on bronchoalveolar lavage technique as an evaluation of drug migration to lung tissue
Scientific Title
Investigation on bronchoalveolar lavage technique as an evaluation of drug migration to lung tissue
Scientific Title:Acronym
Investigation on bronchoalveolar lavage technique as an evaluation of drug migration to lung tissue
Region
| Japan |
Condition
Condition
Respiratory Disease
Classification by specialty
| Pneumology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We perform BAL in healthy male subjects
1, to investigate adequacy of BAL procedure to evaluate drug migration to lung tissue
2, to investigate precision of BAL technique by analyzing amount and component of BALF, and cell count, erythrocyte count, and differential cell count in BALF.
Basic objectives2
Others
Basic objectives -Others
investigation on procedure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
amount and component of BALF, and cell count, erythrocyte count, and differential cell count in BALF
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
bronchoalveolar lavage
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
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
1, Healthy Japanese male.
2, Subject between 20 and 45(inclusive) year of age.
3, Subject with weight <=40kg and >80kg, and with BMI <=18.5 and =>26.0
4, Subject with no abnormality observed by physician's examinations.
5, Subjects who receives screening examinations within one month prior to the study, and the results are judged as adequate for this study by study physician.
Key exclusion criteria
1, Subject who has allergy or had hypersensitivity to lidocaine and/or azithromycin hydrate. And/or subject with illness which prohibits administration of these substances.
2, Subject with history of drug allergy.
3, Subject who received medical treatment 2 months prior to BAL.
4, Subject who donated more than 400ml or 200ml of blood within 3 months or 1 month prior to BAL, respectively.
5, Subject whose result of screening examinations (include vital sign, 12-lead ECG, and safety laboratory tests) deviates from reference range, and the deviation is judged clinically significant by study physician.
6, Subject who takes drug habitually and/or who abuses alcoholic beverage.
7, Subject who acquired severe medical illness within 4 months prior to BAL.
8, Subject with positive test results of syphilis, HIV antigen/antibody, HBs antigen, and/or HCV antibody. Or subject with sign of infection.
9, Subject who smokes within 6 months prior to BAL.
10, Subject who are considered to be inadequate for this study by study physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanari Shiramoto |
Organization
Medical Co. LTA Hakata Clinic
Division name
Clinical Pharmacology Department
Zip code
Address
5-7F 6-18 Tenyamachi, Hakaka-ku, Fukuoka Ctiy, Fukuoka
TEL
0922837701
masanari-shiramoto@lta-med.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanari Shiramoto |
Organization
Medical Co. LTA Hakata Clinic
Division name
Clinical Pharmacology Department
Zip code
Address
5-7F 6-18 Tenyamachi, Hakaka-ku, Fukuoka Ctiy, Fukuoka
TEL
0922837701
Homepage URL
masanari-shiramoto@lta-med.com
Sponsor or person
Institute
Medical Co. LTA Clinical Pharmacology Center
Institute
Department
Personal name
Funding Source
Organization
Taisho Pharmaceutical Co., Ltd.
Medical Co. LTA Hakata Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2014 | Year | 01 | Month | 18 | 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
| 2013 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 18 | Day |
Last modified on
| 2014 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015066
