UMIN-CTR ----------------------------------------

一般向け試験名/Public title

日本語

英語
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.

一般向け試験名略称/Acronym

日本語

英語
A study to examine changes in exposure to cigarette smoke chemicals when a smoker switches to using a tobacco heating product.

科学的試験名/Scientific Title

日本語

英語
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.

科学的試験名略称/Scientific Title:Acronym

日本語

英語
A study to examine changes in exposure to cigarette smoke chemicals when a smoker switches to using a tobacco heating product.

試験実施地域/Region

日本/Japan

対象疾患名/Condition

日本語

英語
Cigarette smoking

疾患区分1/Classification by specialty

成人/Adult

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語

英語
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.

目的2/Basic objectives2

その他/Others

目的2 -その他詳細/Basic objectives -Others

日本語

英語
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.

試験の性質1/Trial characteristics_1

探索的/Exploratory

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

該当せず/Not applicable

主要アウトカム評価項目/Primary outcomes

日本語

英語
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.

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
Biomarkers of Biological Effect (BoBE): 8-Epi-PGF2alpha Type III and white blood cell count.
PK endpoints: tmax, Cmax and AUC0-last.

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

オープン/Open -no one is blinded

コントロール/Control

実薬・標準治療対照/Active

層別化/Stratification

いいえ/NO

動的割付/Dynamic allocation

いいえ/NO

試験実施施設の考慮/Institution consideration

施設を考慮していない/Institution is not considered as adjustment factor.

ブロック化/Blocking

いいえ/NO

割付コードを知る方法/Concealment

知る必要がない/No need to know

群数/No. of arms

6

介入の目的/Purpose of intervention

教育・カウンセリング・トレーニング/Educational,Counseling,Training

介入の種類/Type of intervention

その他/Other

介入1/Interventions/Control_1

日本語

英語
Regular cigarette smoking, for 5 days after 2 day baseline period.

介入2/Interventions/Control_2

日本語

英語
Switch from regular cigarette smoking to developmental THP use for 5 days after 2 day baseline period.

介入3/Interventions/Control_3

日本語

英語
Mentholated cigarette smoking, for 5 days after 2 day baseline period.

介入4/Interventions/Control_4

日本語

英語
Switch from mentholated cigarette smoking to mentholated developmental THP use for 5 days after 2 day baseline period.

介入5/Interventions/Control_5

日本語

英語
Switch from regular cigarette smoking to marketed THP use for 5 days after 2 day baseline period.

介入6/Interventions/Control_6

日本語

英語
Abstain from use of any tobacco products for 5 days after 2 day baseline period.

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

23

歳/years-old

より上/<

年齢（上限）/Age-upper limit

55

歳/years-old

未満/>

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語

英語
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.

除外基準/Key exclusion criteria

日本語

英語
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.

目標参加者数/Target sample size

180

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名
ミドルネーム
姓	Yoshihara Tatsuya

所属組織/Organization

日本語

英語
Fukuoka Mirai Hospital

所属部署/Division name

日本語

英語
Clinical Research Centre

郵便番号/Zip code

住所/Address

日本語

英語
3-5-1, Kashiiteruha, Higashi-ku, Fukuoka

電話/TEL

092-662-3608

Email/Email

tatsuya-yoshihara@lta-med.com

試験問い合わせ窓口担当者/Name of contact person

日本語

名
ミドルネーム
姓

英語

名
ミドルネーム
姓	Ian Fearon

組織名/Organization

日本語

英語
British American Tobacco (Investments) Limited

部署名/Division name

日本語

英語
Clinical Research

郵便番号/Zip code

住所/Address

日本語

英語
Regents Park Road, Southampton, SO15 8TL, U.K.

電話/TEL

4402380588641

試験のホームページURL/Homepage URL

Email/Email

ian_fearon@bat.com

機関名/Institute

日本語
その他

英語
British American Tobacco (Investments) Limited

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
British American Tobacco (Investments) Limited Research and Development

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

営利企業/Profit organization

研究費拠出国/Nationality of Funding Organization

日本語

英語
British

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語

英語

住所/Address

日本語

英語

電話/Tel

Email/Email

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2016

年

11

月

24

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

組み入れ参加者数/Number of participants that the trial has enrolled

主な結果/Results

日本語

英語

主な結果入力日/Results date posted

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

参加者募集終了‐試験継続中/No longer recruiting

プロトコル確定日/Date of protocol fixation

2016

年

11

月

18

日

倫理委員会による承認日/Date of IRB

登録・組入れ開始（予定）日/Anticipated trial start date

2017

年

01

月

20

日

フォロー終了(予定)日/Last follow-up date

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2016

年

11

月

24

日

最終更新日/Last modified on

2017

年

05

月

26

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000028686

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028686