UMIN-CTR Clinical Trial

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

Cigarette smoking

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

British American Tobacco (Investments) Limited

Institute

Department

Personal name

Organization

British American Tobacco (Investments) Limited Research and Development

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

British

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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