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

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 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


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

Value
https://center6.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