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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002472
Receipt No. R000003031
Scientific Title A pharmacokinetics study of nicotine for A-801 in healthy adult male smokers
Date of disclosure of the study information 2010/07/31
Last modified on 2010/07/30

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Basic information
Public title A pharmacokinetics study of nicotine for A-801 in healthy adult male smokers
Acronym A pharmacokinetics study for A-801
Scientific Title A pharmacokinetics study of nicotine for A-801 in healthy adult male smokers
Scientific Title:Acronym A pharmacokinetics study for A-801
Region
Japan

Condition
Condition Smokers
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the nicotine pharmacokinetics including exposure level during the use of A-801 in comparison with a popular commercial tobacco product
Basic objectives2 Others
Basic objectives -Others To investigate the nicotine pharmacokinetics
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the nicotine pharmacokinetics including exposure level during the use of A-801 in comparison with a popular commercial tobacco product
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 Washout period
=> Step1: Use of A-801
=> Washout period
=> Step2: Use of a popular commercial tobacco product
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
40 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 step 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
Institute JAPAN TOBACCO INC.
Institute
Department

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 07 Month 31 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
2009 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 09 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
2009 Year 09 Month 09 Day
Last modified on
2010 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003031

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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