UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024988 |
|---|---|
| Receipt number | R000028686 |
| Scientific Title | A randomised, controlled, multi-centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional combustible cigarette to the glo tobacco heating product. |
| Date of disclosure of the study information | 2016/11/24 |
| Last modified on | 2017/05/26 16:14:05 |
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Basic information
Public title
A randomised, controlled, multi-centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional combustible cigarette to the glo tobacco heating product.
Acronym
A study to examine changes in exposure to cigarette smoke chemicals when a smoker switches to using a tobacco heating product.
Scientific Title
A randomised, controlled, multi-centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional combustible cigarette to the glo tobacco heating product.
Scientific Title:Acronym
A study to examine changes in exposure to cigarette smoke chemicals when a smoker switches to using a tobacco heating product.
Region
| Japan |
Condition
Condition
Cigarette smoking
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively assess within-arm changes in biomarkers of exposure (BoE) and biomarkers of biological effect (BoBE) following a forced switch from a conventional cigarette (commercial cigarette) to a tobacco heating product or cessation.
Basic objectives2
Others
Basic objectives -Others
To assess differences between arms in BoE and BoBE following a switch from a conventional cigarette to a THP or cessation.
To determine nicotine PK parameters.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Biomarkers of exposure (BoE): CO, TNeq, total NNAL, total NNN, 3-HPMA, HMPMA, S-PMA, MHBMA, CEMA, 4-ABP, o-Tol, 2-AN, 1-OHP, HEMA, AAMA and GAMA.
Key secondary outcomes
Biomarkers of Biological Effect (BoBE): 8-Epi-PGF2alpha Type III and white blood cell count.
PK endpoints: tmax, Cmax and AUC0-last.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Regular cigarette smoking, for 5 days after 2 day baseline period.
Interventions/Control_2
Switch from regular cigarette smoking to developmental THP use for 5 days after 2 day baseline period.
Interventions/Control_3
Mentholated cigarette smoking, for 5 days after 2 day baseline period.
Interventions/Control_4
Switch from mentholated cigarette smoking to mentholated developmental THP use for 5 days after 2 day baseline period.
Interventions/Control_5
Switch from regular cigarette smoking to marketed THP use for 5 days after 2 day baseline period.
Interventions/Control_6
Abstain from use of any tobacco products for 5 days after 2 day baseline period.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 23 | years-old | < |
Age-upper limit
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects will be males or females of Japanese origin and between 23 and 55 years of age,
inclusive.
2. Subjects will have a body mass index (BMI) between 17.6 and 32.0 kg/m2, inclusive; a body
weight exceeding 50 kg (males) or 40 kg (females)
3. Subjects will be in good health, as judged by the PI or designee based on medical history,
physical examination, vital signs assessment, 12-lead ECG, clinical laboratory evaluations and
lung function tests
4. Subjects will have given their written informed consent to participate in the study and will
have agreed to abide by the study restrictions.
5. Subjects must demonstrate the ability to comprehend the Informed Consent Form (ICF), be
able to communicate well with the PI or their appropriately qualified designee, understand and
comply with the requirements of the study, and be judged suitable for the study in the opinion of
the PI or their appropriately qualified designee.
6. Subjects will be regular smokers of factory-made cigarettes whose chosen brand is within
the ISO tar bands 6 mg to 8 mg.
7. Subjects will have smoked their chosen brand for a minimum of 6 months and will have smoked for at least 3 consecutive years prior to Screening.
8. Subjects will typically smoke at least 10 and a maximum of 30 cigarettes per day and must
have a urine cotinine level >200 ng/mL and an exhaled breath CO level >10 ppm at Screening.
Key exclusion criteria
1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a barrier method of contraception in addition to a second
highly effective method of contraception used by their female partners or to refrain from donating sperm from Admission until the end of the safety Follow-up period.
2. Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception from the time of signing the ICF until the end of the safety Follow-up period.
3. Female subjects who are pregnant or breastfeeding.
4. Subjects who have an acute illness requiring treatment within 4 weeks prior to Admission.
5. Subjects who have regularly used any nicotine or tobacco product other than commercially manufactured filter cigarettes within 14 days of Screening.
6. Subjects who are self-reported non-inhalers.
7. Subjects who, prior to enrolment, are planning to quit smoking in the next 12 months.
8. Subjects who have serum hepatitis; are carriers of HBsAg; are carriers of the hepatitis C antibody; have a positive result for the test for HIV antibodies; or have syphilis.
9. Subjects who have used prescription or OTC bronchodilator medication to treat a chronic condition within the 12 months prior to Admission.
10. Subjects who have any clinically relevant abnormal findings on the physical examination, medical history, ECG, lung function tests or clinical laboratory panel.
11. Subjects who have, or who have a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the PI, would jeopardise the safety of the subject or impact on the validity of the study results.
12. Subjects who have previously been diagnosed with any form of malignancy.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihara Tatsuya |
Organization
Fukuoka Mirai Hospital
Division name
Clinical Research Centre
Zip code
Address
3-5-1, Kashiiteruha, Higashi-ku, Fukuoka
TEL
092-662-3608
tatsuya-yoshihara@lta-med.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ian Fearon |
Organization
British American Tobacco (Investments) Limited
Division name
Clinical Research
Zip code
Address
Regents Park Road, Southampton, SO15 8TL, U.K.
TEL
4402380588641
Homepage URL
ian_fearon@bat.com
Sponsor or person
Institute
British American Tobacco (Investments) Limited
Institute
Department
Personal name
Funding Source
Organization
British American Tobacco (Investments) Limited Research and Development
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
British
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 | 24 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 20 | 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
| 2016 | Year | 11 | Month | 24 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028686
