UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003604
Receipt number R000004373
Scientific Title A study of the changes of biomarkers for A-703 in healthy adult male smokers
Date of disclosure of the study information 2010/11/01
Last modified on 2010/11/16 11:48:18

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Basic information

Public title

A study of the changes of biomarkers for A-703 in healthy adult male smokers

Acronym

A biomarker study for A-703

Scientific Title

A study of the changes of biomarkers for A-703 in healthy adult male smokers

Scientific Title:Acronym

A biomarker study for A-703

Region

Japan


Condition

Condition

Smokers

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the change of Biomarkers and the nicotine pharmacokinetics during smoking of A-703

Basic objectives2

Others

Basic objectives -Others

To investigate the change of Biomarkers and the nicotine pharmacokinetics

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To investigate the change of Biomarkers and the nicotine pharmacokinetics during smoking of A-703

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

Food

Interventions/Control_1

Smoking of a commercial tobacco product (for one day) => Smoking of A-703 (for nine days)

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

21 years-old <=

Age-upper limit

50 years-old >

Gender

Male

Key inclusion criteria

1. Subjects who sign the study-specific consent form
2. Subjects who are confirmed to be in good health through the screening process
3. Smokers
4. Subjects who do not plan to quit smoking over the study period (from screening to Visit 2)
etc.

Key exclusion criteria

1. Subjects who have regular use experience of hand-rolled cigarette, cigarillo, cigar, pipe, smokeless tobacco or chewing tobacco
2. Subjects who donate 200ml or more of blood within 4 weeks before screening, or who donate 400ml or more of blood within 12 weeks before screening (including blood donation)
etc.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsuyoshi Moriyama

Organization

JAPAN TOBACCO INC.

Division name

Product Science Division, R&D Group, Tobacco Business Headquarters

Zip code


Address

1-17-7, Yokokawa, Sumida-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

JAPAN TOBACCO INC.

Division name

Product Science Division, R&D Group, Tobacco Business Headquarters

Zip code


Address

1-17-7, Yokokawa, Sumida-ku, Tokyo

TEL


Homepage URL


Email



Sponsor or person

Institute

JAPAN TOBACCO INC.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2010 Year 11 Month 01 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

2010 Year 04 Month 26 Day

Date of IRB


Anticipated trial start date

2010 Year 05 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

2010 Year 05 Month 12 Day

Last modified on

2010 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004373


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name