UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062769 |
|---|---|
| Receipt number | R000071864 |
| Scientific Title | A Study to Investigate Nicotine Pharmacokinetics Following Use of PA in Healthy Adults Who Smoke Combustible Cigarettes |
| Date of disclosure of the study information | 2026/09/11 |
| Last modified on | 2026/09/01 17:56:56 |
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Basic information
Public title
A Study to Investigate Nicotine Pharmacokinetics Following Use of PA in Healthy Adults Who Smoke Combustible Cigarettes
Acronym
A Study to Investigate Nicotine Pharmacokinetics Following Use of PA in Healthy Adults Who Smoke Combustible Cigarettes
Scientific Title
A Study to Investigate Nicotine Pharmacokinetics Following Use of PA in Healthy Adults Who Smoke Combustible Cigarettes
Scientific Title:Acronym
A Study to Investigate Nicotine Pharmacokinetics Following Use of PA in Healthy Adults Who Smoke Combustible Cigarettes
Region
| Japan |
Condition
Condition
Smokers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this single-center, randomized, open-label, crossover study is to investigate nicotine pharmacokinetics following use of PA in healthy adults who smoke combustible cigarettes under confined conditions, using combustible cigarettes as comparators.
Basic objectives2
Others
Basic objectives -Others
The objective of this single-center, randomized, open-label, crossover study is to investigate nicotine pharmacokinetics following use of PA in healthy adults who smoke combustible cigarettes under confined conditions, using combustible cigarettes as comparators.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma nicotine concentration profiles and nicotine pharmacokinetic parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
[Non-menthol smokers] Use of non-menthol flavor cigarette (Day1) - Use of non-menthol flavor PA (Day2)
Interventions/Control_2
[Non-menthol smokers] Use of non-menthol flavor PA (Day1) - Use of non-menthol flavor cigarette (Day2)
Interventions/Control_3
[Menthol smokers] Use of menthol flavor cigarette (Day1) - Use of menthol flavor PA (Day2)
Interventions/Control_4
[Menthol smokers] Use of menthol flavor PA (Day1) - Use of menthol flavor cigarette (Day2)
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 and Female
Key inclusion criteria
-Individuals who have smoked commercial combustible cigarettes for 1 year or more and have a positive urine cotinine test at screening
-Individuals who are judged by the investigator to be in good health on the basis of the results of clinical assessments performed by the start of the investigation period on Day1
-Individuals who are willing to participate in the study, understand the informed consent document, and provide written or electronic informed consent, etc.
Key exclusion criteria
-Individuals who have regularly used any tobacco products other than commercial combustible cigarettes within 4 weeks prior to Day 1
-Females who are or may be pregnant, or who are lactating
-Individuals who are employees of the tobacco industry or any other parties involved in the study, etc.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
JAPAN TOBACCO INC.
Division name
Scientific and Regulatory Affairs, Tobacco Business
Zip code
105-6927
Address
Kamiyacho Trust tower, 4-1-1, Toranomon, Minato-Ku, Tokyo
TEL
080-8131-5689
naoki.miura@jt.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Suzuki |
Organization
JAPAN TOBACCO INC.
Division name
Scientific and Regulatory Affairs, Tobacco Business
Zip code
105-6927
Address
Kamiyacho Trust tower, 4-1-1, Toranomon, Minato-Ku, Tokyo
TEL
080-2044-4311
Homepage URL
takuya.a.suzuki@jt.com
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
Hakata Clinic Institutional Review Board
Address
6-18, Tenyamachi, hakata-ku, Fukuoka-shi, Fukuoka prefecture
Tel
092-283-7701
hakataclinic-irb@lta-med.com
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
| 2026 | Year | 09 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071864
