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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024988
Receipt No. 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

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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
Email 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
Email ian_fearon@bat.com

Sponsor
Institute British American Tobacco (Investments) Limited
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028686

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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