UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017297 |
|---|---|
| Receipt number | R000020059 |
| Scientific Title | A pharmacokinetics study of nicotine for B-001 in healthy adult male smokers |
| Date of disclosure of the study information | 2016/11/21 |
| Last modified on | 2016/11/21 16:26:22 |
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Basic information
Public title
A pharmacokinetics study of nicotine for B-001 in healthy adult male smokers
Acronym
A pharmacokinetics study for B-001
Scientific Title
A pharmacokinetics study of nicotine for B-001 in healthy adult male smokers
Scientific Title:Acronym
A pharmacokinetics study for B-001
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 following the use of B-001 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
Nicotine pharmacokinetic parameters (Cmax, Tmax and AUClast)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Period1:Use of B-001 - Period2:Use of CC1
Interventions/Control_2
Period1:Use of CC1 - Period2:Use of B-001
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
- Subjects who sign the study-specific consent form
- Subjests who are confirmed to be in good health through the screening process
- Smokers
etc.
Key exclusion criteria
- Subjects who have used smoking cessation medications within 4 weeks of the screening, or plan to use the medication until the end of the study
- Subjects whose blood was collected more than 200 ml within 4 weeks prior to the screening, or more than 400 ml within 12weeks prior to the screening (including blood donation)
etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Futamura |
Organization
JAPAN TOBACCO INC.
Division name
Scientific Product Assessment Center, Tobacco Business Headquarters
Zip code
Address
6-2, Umegaoka, Aoba-ku, Yokohama, Kanagawa
TEL
045-973-5611
yasuyuki.futamura@jt.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aki Nonaka |
Organization
JAPAN TOBACCO INC.
Division name
Scientific Product Assessment Center, Tobacco Business Headquarters
Zip code
Address
6-2, Umegaoka, Aoba-ku, Yokohama, Kanagawa
TEL
045-973-5611
Homepage URL
aki.nonaka@jt.com
Sponsor or person
Institute
JAPAN TOBACCO INC.
Institute
Department
Personal name
Funding Source
Organization
JAPAN TOBACCO INC.
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
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
| 2016 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 27 | Day |
Last modified on
| 2016 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020059
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
