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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012895
Receipt No. 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

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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
Email 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
Email masanari-shiramoto@lta-med.com

Sponsor
Institute Medical Co. LTA Clinical Pharmacology Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015066

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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